Published: 5 December 2018
Revised: 7 June 2019
Committees
Minutes of the 61st meeting of the Medicines Classification Committee held in Wellington on 2 November 2018 at 9:30 am
Present:
Dr Stewart Jessamine (Chair)
Andi Shirtcliffe (from agenda item 5.1 onwards)
Angela Harwood
Kerri Miedema
Dr David (Buzz) Boothman Burrell
Prof Les Toop
In attendance (from Medsafe):
Jessica Lo (Secretary)
Alison Cossar (Manager, Product Regulation Branch)
Courtenay Kularatne (Advisor, Product Regulation Branch)
Outi Kolju (Advisor, Product Regulation Branch)
Derek Fitzgerald (Manager, Compliance Management Branch)
Maria Storey (Senior Advisor, Clinical Risk Management Branch)
Dr Geraldine Hill (Senior Medical Advisor, Clinical Risk Management Branch)
Observers (for agenda item 6.1 only):
Michelle Kapinga (General Manager, Aspen Pharmacare)
Dr Natalie Gauld (Director, Natalie Gauld Ltd)
Apologies:
None
| 1 | Welcome |
| The Chair opened the 61st meeting at 9:30 am and welcomed members and guests | |
| 2 | Apologies |
| No apologies were received. | |
| 3 | Confirmation of the minutes of the 60th meeting held on 26 April 2018 |
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The following amendments were noted about the minutes of the 60th meeting: Correction of Dr Burrell's name to 'Dr D Boothman Burrell'. Agenda item 5.3. The last sentence has been changed for clarification purposes to 'The Committee agreed that they are interested in learning about the impact of reclassification decisions and acknowledged that this may be a complex issue to analyse due to the limitations of the data available'. The remainder of the minutes of the 60th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair. |
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| 4 | Declaration of conflicts of interest |
| The Conflict of Interest forms were returned to the Secretary. No new conflicts of interest were declared. The Chair concluded that there were no interests which would pose a conflict with any of the items on the agenda. | |
| 5 | Matters arising |
| 5.1 | Objections to recommendations made at the 60th meeting |
| The deadline for intentions to object to a recommendation made at the 60th meeting, together with a statement of the grounds on which the objection would be made, was 29 June 2018. | |
| 5.1.1 | Reclassification of modified release paracetamol - objection to the proposed recommendation that modified release paracetamol be reclassified from a pharmacy-only medicine to a restricted medicine. |
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A valid objection (PDF, 410 KB, 6 pages) was received regarding the Committee's recommendation to reclassify modified release paracetamol from a pharmacy-only medicine to a restricted medicine. This objection has been accepted as valid on the basis that new safety information has become available and the MCC did not consider all the safety and benefit issues correctly. This was a Medsafe submission (PDF, 916 KB, 9 pages) proposing the reclassification of modified-release paracetamol from pharmacy-only medicine to restricted medicine. Comments Seven comments were received about the objection to the recommendation made at the 60th meeting about the reclassification of modified release paracetamol. Three comments supported the recommendation to reclassify modified release paracetamol to a restricted medicine. Four comments supported retaining the current classification as a pharmacy-only medicine. Discussion The Committee considered the comments received during consultation, including the strong support from the MARC to reclassify modified release paracetamol. Product label changes submitted by GSK as part of the objection were discussed. However, it was pointed out that the GSK brand is not the only brand of modified-release paracetamol on the market. The Committee commented how the new information provided by GSK was an update about the regulatory situation in Denmark, rather than new safety data. Modified-release paracetamol was suspended from the European market in December 2017. The Committee noted that in Denmark the marketing suspension was lifted and that modified-release paracetamol is classified as a prescription medicine in Europe. The Committee commented how in Australia, the classification of modified release paracetamol was also being considered. The submission by the TGA to the ACMS included information about the regulatory situation in Europe and New Zealand. The ACMS is to consider modified- release paracetamol in 2019. Overdose with modified-release paracetamol is difficult to manage because of the unpredictable pharmacokinetics. The Committee remained concerned about the risk of not identifying that a patient may have overdosed on the modified-release formulation and that the standard paracetamol overdose guidelines and nomogram do not apply in this situation. The Committee was advised that the Australasian guidelines for paracetamol overdose are currently under review. The Committee noted that the number of calls concerning overdose with modified-release paracetamol received by the Poisons Centre is a small proportion of all calls concerning paracetamol overdose. However, a significant proportion of the calls concerning modified-release paracetamol are due to unintentional overdose (incorrect dose taken). The Committee were reminded that products formulated as modified-release paracetamol are safe when taken at the normal therapeutic dose. Consumer interaction with a pharmacist was considered important because pharmacists can advise consumers of the correct dosing frequency and that other paracetamol-containing products should be avoided while taking this medicine. The Committee concurred that a restricted classification was desirable because it maintains OTC access while ensuring that consumers receive adequate information to ensure the medicine is taken correctly. The Committee acknowledged that there was the potential for reduced availability of modified-release paracetamol. However, the Committee was satisfied that there are alternative effective immediate release paracetamol products that are readily available. Recommendation That modified release paracetamol should be reclassified from a pharmacy-only medicine to a restricted medicine. |
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| 5.2 | Update on outstanding agenda items from the 60th meeting |
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(Agenda item 6.3 Influenza vaccine - proposed amendment to 'prescription except when' classification) The Committee recommended that 'registered pharmacists' should be interpreted to include registered intern pharmacists. Medsafe is of the opinion that the term 'pharmacist', as defined in the Medicines Act 1981, is a person formally registered with the Pharmacy Council to practice as a pharmacist, as opposed to an intern pharmacist. The term 'pharmacist' is defined in the Medicines Act 1981 as: "pharmacist" means health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competency Assurance Act 2003 as a practitioner of the profession of pharmacy. The terms 'registered pharmacist' or 'registered intern pharmacist' are not terms that are defined in the Medicines Act. They are the scopes of practice prescribed by the Pharmacy Council. It is advisable to interpret the term 'pharmacist' as it is defined in the Medicines Act. The scopes of practice prescribed by the Pharmacy Council suggest that the Council do not consider an intern pharmacist to be 'a practitioner of the profession of pharmacy' until the intern pharmacist is formally registered to practice as a pharmacist. Given this, it is advisable to interpret the term 'pharmacist' to be a person formally registered with the Pharmacy Council to practice as a pharmacist (as opposed to an intern pharmacist) for the purposes of the Medicines Act. With this understanding, this proposal will not be considered again in the next meeting of the MCC. Instead, it will be considered as part of the Ministry of Health's project on broadening vaccinator accreditation. Discussion The Committee considered the outcome of this opinion and suggested that Medsafe should continue this discussion with the Pharmacy Council if required. Recommendation A recommendation was not required. |
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| 5.3 | Referred submission from the 60th meeting - agenda item 6.4 melatonin - proposed reclassification from prescription medicine to a restricted medicine |
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Purpose The Committee recommended that Medsafe should consult again on the reclassification of melatonin to a restricted medicine because the published agenda of the 60th meeting of the Medicines Classification Committee did not include this submission's alternative proposal. Medsafe will consult on the alternative proposal described in this submission (PDF, 911 KB, 17 pages) for reclassification from a prescription medicine to a restricted medicine. Any feedback received during the consultation process will be considered at the 61st meeting of the Committee. Background information Melatonin was classified urgently as a prescription medicine at the 16th meeting on 24 April 1996. Before classification a number of supplements had appeared on the New Zealand market bearing therapeutic claims. Melatonin was classified because it is a hormone and at the time there was insufficient data available regarding its effects and safety profile. At the 47th meeting on 1 May 2012, the Committee considered the submission for reclassification of melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over. The Committee recommended that a revised submission to reclassify melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over, would be considered at a future meeting. At the 48th meeting on 30 October 2012, the Committee recommended that melatonin 2 mg prolonged release tablets should not be reclassified from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over. More time on the market with experience in New Zealand with the proposed indication was required. At the 49th meeting on 17 June 2013, melatonin was discussed again by the Committee. In response to a request from Aspen Pharma Pty Limited, the Committee confirmed what would be required if another submission for reclassification was made at a later meeting. The submission should address the:
If another submission was received within a year, it was considered appropriate to address the outstanding issues only. However, if a submission for reclassification was made in five years' time, a full submission would be required. At the 57th meeting on 1 November 2016, a submission for the reclassification of melatonin was withdrawn before the meeting. At the 58th meeting on 16 May 2017, a submission for the reclassification of melatonin was withdrawn before the meeting. At the 59th meeting on 26 April 2018, a proposal to reclassify melatonin was discussed by the Committee. The proposal contained two proposals: that melatonin should be a dietary supplement or that melatonin should be reclassified as a restricted medicine. The second proposal was not included in the agenda and so Medsafe consulted again on the second proposal. It was clarified during the meeting that the proposal relates to melatonin 3 mg tablets. Comments Eight comments were received about the referred submission from the 60th meeting for the proposed reclassification of melatonin from a prescription medicine to a restricted medicine. Two comments supported the reclassification. Four comments opposed the reclassification. Two comments did not state a preference for classification. Discussion This item was discussed in conjunction with item 6.1 melatonin prolonged release 2 mg tablets. Aspects of this discussion may also applicable to item 6.1 and vice versa. The Committee agreed that melatonin has a good safety profile, as discussed at the 60th meeting. Melatonin was considered a safer option than alternative pharmacological treatments for insomnia, such as sedating antihistamines that are classified as a restricted medicines. The Committee pointed out that pharmacists already have experience at providing advice about insomnia. There are sedating antihistamines classified as restricted medicines for the treatment of insomnia and also a range of health products for insomnia that are available in pharmacies. The Committee agreed that the treatment of insomnia is best managed by a health care professional rather than by self-diagnosis. Insomnia as a potential symptom of mental health illness and risk of suicide was raised. Therefore it was decided that advice from a health care professional about the treatment of insomnia was important. The Committee pointed out that pharmacists should also be able to provide alternative pathways other than the GP, should a patient require it. Alternative pathways for referral could include psychosocial support or talk therapy. The Committee will write to the Pharmaceutical Society of New Zealand and the Pharmacy Council about identifying alternative pathways. The Committee acknowledged the mixed regulatory situation for melatonin overseas. In Australia, melatonin is classified as a prescription medicine. In America, melatonin is considered as a dietary supplement and is widely available. Melatonin has pharmacological actions and has been categorised as a medicine in New Zealand by Medsafe. The Committee examined how the classification of a medicine affects rules around importation of medicines containing melatonin from overseas. There were concerns about how personally imported unapproved products did not involve a health care professional and that all relevant information may not be readily available. The Committee was concerned that consumers seeking treatment for insomnia would have missed an opportunity to get advice from a health care professional. The range of natural health care products for the treatment of insomnia was raised. The quantity of natural health care products sold for insomnia was uncertain because there was no readily accessible records available on sales of natural health care products. Recommendation That melatonin 3 mg tablets should be reclassified from a prescription medicine to 'prescription except when', with the same conditions as described for melatonin prolonged release 2 mg tablets (agenda item 6.1). The following conditions have been recommended:
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| 5.4 | Out-of-session meeting for New Biological Entities in Bexsero |
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An out-of-session meeting took place in May 2018 regarding the classification of the NBEs in Bexsero. The MCC recommended that the NBEs in Bexsero does not require a separate classification entry and are adequately captured by the existing entry for Meningococcal vaccine. The NBEs in Bexsero are:
Discussion This recommendation was confirmed by the Committee. Recommendation No further recommendation was required. |
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| 6 | Submissions for reclassification |
| 6.1 | Melatonin prolonged release 2 mg tablets - proposed reclassification
from prescription medicine to prescription except when classification
(Circadin, Aspen Pharmacare and Natalie Gauld Ltd) |
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Purpose This is a submission (PDF, 510 KB, 22 pages) from Aspen Pharmacare and Natalie Gauld Ltd proposing the reclassification of melatonin in prolonged release 2 mg oral dose form from a prescription medicine to prescription except when provided at a strength of 2 mg prolonged release to people who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand approved training programme on melatonin, when sold in the manufacturer's original pack that has received the consent of the Minister or Director-General to their distribution as medicines, by a registered pharmacist who has successfully completed the approved training programme. Background The recent history for the classification of melatonin has been summarised earlier by agenda item 5.3. Comments Ten comments were received about the proposed reclassification of melatonin prolonged release 2 mg tablets from a prescription medicine to 'prescription except when'. Eight comments supported the reclassification. Two comments did not state a preference for classification. There were no comments received in opposition to this proposed reclassification. Discussion This item was discussed in conjunction with item 5.3 melatonin 3 mg tablets. Aspects of this discussion may also applicable to item 5.3 and vice versa. Michelle Kapinga and Natalie Gauld were invited by the Committee to answer questions about their proposal. Questions were asked about what the pharmacist was expected to do following the 13 week supply if the patient presents again and that there should be alternative referral pathways in addition to the GP. It was expected that both these issues will be addressed in the screening tool and/or training programme. The prolonged release and immediate release uses of melatonin were compared and the observers explained that prolonged release is intended to be used routinely for the 13 week period (rather than intermittently) for re-education and resetting of good sleep hygiene. The observers left the meeting. The Committee was reminded that Circadin had demonstrated an acceptable risk-benefit profile and was consented in 2011. The currently approved indications for Circadin are: 'Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over'. The use of melatonin in children has not been approved and therefore any use in children would be considered off-label and not suitable for supply by a pharmacist. Pharmacists have experience managing insomnia and there are medicines currently classified as restricted for the treatment of insomnia. The proposal will make available a medicine with an acceptable risk-benefit profile and efficacy at a system level structure. A screening tool was considered a useful algorithm because it enables an objective and consistent approach to differential diagnosis. However, the Committee highlighted that it was not a substitute for practical training and experience in diagnosis. The Committee understood that the proposed screening tool and model is similar to that for sildenafil. The emerging use of shared electronic health records should help mitigate the likelihood of patients going to multiple pharmacies seeking supply. The screening tool is a good opportunity to have a conversation about depression and mental health. The Committee discussed how the screening tool can be used to support mental health and the value of a screening tool in the mental health area can be more than just a tool for supply of Circadin. Identifying any mental health illness associated with insomnia was considered of high importance. The Committee preferred that the training programme on sleep hygiene should include a strong mental health component and ideally be a joint training programme with other health care professionals. The training programme should include training on the process of diagnosis for insomnia and should contain more referral pathways than the GP. There was concern that deviation from the screening tool may expose patients to potential risk due to misdiagnosis. The Committee discussed how more treatment options, other than pharmacological, are available from a GP and that these options may not be readily available to pharmacists. The Committee will write to the Pharmaceutical Society of New Zealand and the Pharmacy Council about the points raised in the discussions. The proposal for 'prescription except when' is a step towards down-scheduling of this medicine. The Committee was advised how the proposal would mean that melatonin is still classified as a prescription medicine except when supplied in the specified circumstances, and how this does not mean that it is a general sale medicine. A benefit of the proposed classification is that the sales of this medicine will be recorded. This was considered an opportunity to learn about the use of melatonin to enable evaluation following implementation. The Committee suggested that the sponsor of Circadin, Aspen Pharmacare, should undertake their own evaluation and that Medicines Control may also wish to include melatonin in their audits. The Committee concluded that the risk of misdiagnosis was outweighed by the benefit of engaging potentially at-risk patients and the reduction in the use of more harmful alternative pharmacological treatments for insomnia. Recommendation That melatonin prolonged release 2 mg tablets should be reclassified from a prescription medicine to 'prescription except when' with the following conditions:
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| 6.2 | Dextromethorphan, opium tincture, squill oxymel and pholcodine
- proposed reclassification from general sale and pharmacy only
medicines to restricted medicines
(Medsafe) |
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Purpose This is a submission (PDF, 638 KB, 17 pages) from Medsafe proposing the reclassification of cough medicines containing the active ingredients dextromethorphan, opium tincture, squill oxymel and pholcodine from general sale and pharmacy-only medicines to restricted medicines. Background information Dextromethorphan At the 27th meeting on 23 May 2002 the Committee recommended that the classification of dextromethorphan remain unchanged because there was no evidence of abuse of general sale products in New Zealand. At the 30th meeting on 26 November 2003 the Committee recommended that over-the-counter packs of dextromethorphan should be limited to packs containing 600 mg or less and with a recommended daily dose of not more than 120 mg. At the 37th meeting on 17 May 2007 the Committee recommended that, on the grounds of harmonisation at the less restrictive level, the Australian National Drugs and Poisons Schedule Committee should be recommended to harmonise with New Zealand on the classification of dextromethorphan. At the 43rd meeting on 13 April 2010, the Committee considered dextromethorphan and the outcome was that Medsafe monitors reports of abuse for dextromethorphan. Opium tincture The Committee has not considered opium tincture recently. Squill oxymel The Committee has not considered squill oxymel recently. Squill oxymel is currently not scheduled in Part 1 of the Medicines Regulations 1984 and is considered a general sales medicine. Pholcodine At the 55th meeting, the Committee considered a submission to change the classification wording for numerous substances, including pholcodine. The submission proposed to remove references to approved or manufacturer's original packs. The Committee deferred a decision due to insufficient information. Comments Thirteen comments were received about the proposed reclassification of dextromethorphan, opium tincture, squill oxymel and pholcodine from general sale and pharmacy only medicines to restricted medicines. Dextromethorphan Eleven comments were received about the proposed reclassification of dextromethorphan to a restricted medicine. Four comments supported the reclassification. Five comments opposed the reclassification. One comment supported reclassifying to a pharmacy medicine but not a restricted medicine. One comment did not state a preference for classification. Opium tincture Six comments were received about the proposed reclassification of opium tincture to a restricted medicine. Five comments supported the reclassification. One comment opposed the reclassification. Squill oxymel Seven comments were received about the proposed reclassification of squill oxymel to a restricted medicine. Five comments supported the reclassification. Two comments opposed the reclassification. Pholcodine Eight comments were received about the proposed reclassification to a restricted medicine. Two comments supported the reclassification. Six comments opposed the reclassification. Discussion The Committee discussed how dextromethorphan had been connected to abuse in New Zealand particularly amongst teenagers. The Committee noted how this has not been reflected in the limited number reports from CARM or the Poisons centre on adverse events related to dextromethorphan. A restricted entry will allow importation of unapproved medicines containing dextromethorphan, however, internet orders of dextromethorphan by teenagers was considered unlikely. The Committee understood that the misuse of dextromethorphan is associated with overconsumption by individuals (amended at the 62nd meeting of the MCC) and therefore a restricted entry may mitigate this risk. Secretary’s note The words ‘volume of sales’ will be reviewed at the 62nd meeting for amendment if necessary to better reflect the discussion that occurred. For example, revising the words to ‘taking excessive quantities’. The regulatory situation for dextromethorphan overseas is mixed. The Committee confirmed that it is not currently scheduled as a controlled drug in New Zealand. Opium tincture and squill oxymel (in combination known as Gee's Linctus) appeared to be a relic and the classification out-dated. The Committee outlined how there are many other safer alternatives available OTC and the risk associated with Gee's Linctus is more comparable to prescription medicines rather than OTC. The Committee agreed that pholcodine has limited potential for abuse. A rare but fatal association with anaphylaxis and neuromuscular blockers and pholcodine was discussed but the evidence for this was considered limited. The Committee discussed how OTC medicines sometimes are not perceived by patients as medicines and therefore it is more difficult to identify this when taking a patient's medication history. However, the Committee concluded that there were minimal safety concerns around pholcodine and that the current classification is appropriate. The Committee agreed that consumers can appropriately self-manage coughs and cold. There are alternative cough and cold products available OTC. The Committee suggested that Medsafe should review the risk-benefit profile and efficacy of pholcodine, which is a grandfathered medicine, and dextromethorphan. Recommendation That dextromethorphan should be reclassified from a general sale and pharmacy-only medicine to a restricted medicine.
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| 7 | New medicines for classification |
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The following new chemical entities were submitted to the Committee for classification. |
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| 7.1 | Linaclotide Constella capsule, 72, 145 and 290 micrograms (TT50-10362, a, b) |
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Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family. Both linaclotide and its active metabolite bind as agonists to the guanylate cyclase-C receptor on the luminal surface of the intestinal epithelium. It is used in the treatment of constipation-predominant irritable bowel syndrome and chronic idiopathic constipation. Recommendation That linaclotide should be classified as a prescription medicine. |
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| 7.2 | Ribociclib succinate
KISQALI film coated tablet, 200 mg (TT50-10426) |
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Recommendation A recommendation was not required because this new chemical entity had already previously been classified following the 60th meeting of the Medicines Classification Committee held on 26 April 2018 |
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| 7.3 | Risankizumab
TRADENAME (risankizumab) solution for injection, 90 mg/mL (TT50-10443) |
| Risankizumab is a humanised monoclonal antibody. The Martindale
currently does not contain any information on risankizumab.
Risankizumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That risankizumab should be classified as a prescription medicine. |
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| 7.4 | Benralizumab
Fasenra solution for injection, 30 mg/mL (TT50-10470) |
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Benralizumab is a humanised monoclonal antibody that binds to the interleukin-5α receptor on eosinophils and basophils, resulting in apoptosis and eosinophil depletion. It is used as add-on maintenance treatment in severe eosinophilic asthma inadequately controlled with standard asthma therapy. The usual dose of benralizumab is 30 mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter, given by subcutaneous injection into the upper arm, thigh, or abdomen. Benralizumab should not be used to treat an acute asthma attack. Benralizumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That benralizumab should be classified as a prescription medicine. |
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| 8 | Harmonisation of the New Zealand and Australian schedules |
| 8.1 | New chemical entities which are not yet classified in New Zealand |
| 8.1.1 | Avelumab (May 2018) |
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Avelumab is a monoclonal antibody indicated for the treatment of Merkel cell carcinoma, metastatic urothelial carcinoma and gastric cancer, including cancer of the gastroesophageal junction. From 1 June 2018, avelumab is classified as a prescription medicine in Australia. Avelumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That avelumab should be classified as a prescription medicine. |
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| 8.1.2 | Baricitinib (November 2017) |
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Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients. From June 2018, baricitinib is classified as prescription medicine in Australia. Recommendation That baricitinib should be classified as a prescription medicine |
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| 8.1.3 | Blinatumomab (May 2018) |
| Bilnatumomab is indicated for the treatment of Philadelphia
chromosome-negative relapsed or refractory B-cell precursor acute
lymphoblastic leukaemia.
From June 2018, bilnatumomab is classified as prescription medicine in Australia. Bilnatumomab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That bilnatumomab should be classified as a prescription medicine. |
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| 8.1.4 | Cerliponase alfa (November 2017) |
| Cerliponase alfa is an orphan drug indicated for the treatment
of neuronal ceroid lipofuscinosis type 2, also known as tripeptidyl
peptidase 1 deficiency.
From June 2018, cerliponase alfa is classified as prescription medicine in Australia. Recommendation That cerliponase alfa should be classified as a prescription medicine. |
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| 8.1.5 | Daratumumab (May 2018) |
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Daratumumab is indicated for use:
From June 2018, daratumumab is classified as prescription medicine in Australia. Daratumumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That daratumumab should be classified as a prescription medicine. |
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| 8.1.6 | Durvalumab (May 2018) |
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Durvalumab is indicated for the treatment of metastatic urothelial carcinoma and non-small cell lung cancer. From June 2018, durvalumab is classified as prescription medicine in Australia. Durvalumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That durvalumab should be classified as a prescription medicine. |
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| 8.1.7 | Inotuzumab ozogamicin (May 2018) |
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Inotuzumab ozogamicin is indicated for treatment of adults with relapsed or refractory CD22-positive B-cell precursor lymphoblastic leukaemia. From June 2018, inotuzumab ozogamicin is classified as prescription medicine in Australia. Inotuzumab ozogamicin is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That inotuzumab ozogamicin should be classified as a prescription medicine. |
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| 8.1.8 | Lifitegrast (May 2018) |
| Lifitegrast is indicated for the topical treatment of dry eye
disease.
From June 2018, lifitegrast is classified as prescription medicine in Australia. Recommendation That lifitegrast should be classified as a prescription medicine. |
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| 8.1.9 | Lonoctocog alfa (May 2018) |
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Lonoctocog alfa is a recombinant single-chain coagulation Factor VIII for use in Haemophilia A. From June 2018, lonoctocog alfa is exempt from the Poisons Standard in Australia because it is captured as a human blood product. Recommendation A recommendation was not required because this biological entity had already previously been classified following the 40th meeting of the Medicines Classification Committee held on 15 November 2008. |
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| 8.1.10 | Midostaurin (May 2018) |
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Midostaurin is indicated for the treatment of acute myeloid leukaemia and systemic mast cell disease. From June 2018, midostaurin is classified as a prescription medicine in Australia. Recommendation That midostaurin should be classified as a prescription medicine. |
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| 8.1.11 | Neratinib (May 2018) |
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Neratinib is indicated as an extended adjuvant treatment for early stage disease of HER2 overexpression, following adjuvant trastuzumab based therapy. From June 2018, neratinib is classified as a prescription medicine in Australia. Recommendation That neratinib should be classified as a prescription medicine. |
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| 8.1.12 | Obeticholic acid (May 2018) |
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Obeticholic acid is indicated for the treatment of primary biliary cirrhosis. From June 2018, obeticholic acid is classified as a prescription medicine in Australia. Recommendation That obeticholic acid should be classified as a prescription medicine. |
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| 8.1.13 | Olaratumab (November 2017) |
| Olaratumab is indicated for the treatment of solid tumours and
is directed against the platelet-derived growth factor receptor
alpha.
From June 2018, olaratumab is classified as a prescription medicine in Australia. Olaratumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That olaratumab should be classified as a prescription medicine. |
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| 8.1.14 | Tezacaftor (November 2017) |
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Tezacaftor is indicated for use in combination with ivacaftor for the treatment of cystic fibrosis in patients who have the genotype for mutations known to be responsive to tezcaftor/ivacaftor. From June 2018, tezacaftor is classified as a prescription medicine in Australia. Tezacaftor is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine. Recommendation That tezacaftor should be classified as a prescription medicine. |
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| 8.1.15 | Voxilaprevir (November 2017) |
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Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease. Voxilaprevir acts as a non-covalent, reversible inhibitor of the NS3/4A protease. Voxilaprevir/sofosbuvir/velpatasvir fixed-dose combination is indicated for the treatment of chronic hepatitis C virus infection in adults. From 1 June 2018, voxilaprevir is classified as a prescription medicine in Australia. Recommendation That voxilaprevir should be classified as a prescription medicine. |
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| 8.2 | Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate) |
| 8.2.1 | Decisions by the Delegate - November 2017 |
| 8.2.1.a | Stenabolic SR9009 and other synthetic REV-ERB agonists |
| Stenabolic is a performance and image enhancing drug. Stenabolic
is an orally active REV-ERBα ligand acting on a heme regulated,
nuclear receptor. Its pharmacological actions suggest they alter
the circadian rhythm in rodents (and likely to do this in humans),
which has implications for sleep, metabolic issues and potentially
mental health problems.
From 1 June 2018, stenabolic and other synthetic REV-ERB agonists are classified as prescription medicines in Australia. Recommendation That stenabolic and other synthetic REV-ERB agonists should be classified as a prescription medicine. |
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| 8.2.1.b | Ibutamoren |
| Ibutamoren is a performance and image enhancing drug. It is
a potent, orally active small molecule (non-peptide) ghrelin analogue
which is exploited pharmacologically as a growth hormone secretagogue.
From June 2018, ibutamoren is classified as a prescription medicine in Australia. At the 49th meeting held on 17 June 2013, the Committee recommended to individually add growth hormone secretagogues to the schedule. Recommendation That ibutamoren should be classified as a prescription medicine. |
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| 8.2.1.c | Melatonan II |
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Melatonan II is a melanocyte stimulating hormone. From 1 June 2018, melatonan II is classified as prescription medicine in Australia. Melatonan II is not specifically scheduled in the Medicines Regulations, but as a melanocyte stimulating hormone, it is captured by the entry for melanocyte stimulating compounds as a prescription medicine. Melatonan II was considered at the 49th meeting when a class entry for melanocyte stimulating hormone was recommended by the Committee. Recommendation That melatonan II should be captured in the entry for melanocyte stimulating compounds as a prescription medicine. |
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| 9 | Agenda items for the next meeting |
| 9.1 | Reclassification of codeine |
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Medsafe advised the Committee that a paper on the reclassification of codeine is being prepared for consideration at the 62nd meeting to be held at the start of next year. The Committee agreed that consultation is an important part of the classification process and suggested ways to improve engagement during consultation. |
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| 10 | General business |
| 10.1 | Outcome of consultation on the guidance document on 'How to change the legal classification of a medicine in New Zealand' |
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The comments received and the outcome of this consultation were discussed. The Committee discussed the involvement of the Pharmacy Council and Pharmaceutical Society in the delivery of training programmes and how to improve the timely implementation of recommendations from the Committee. The revised guidance document is expected to be published in December 2018 and all submissions received for the 63rd meeting should meet the new guidance requirements. |
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| 10.2 | Outcome of consultation on observers at Ministerial Committee Meetings |
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Comments received during this consultation and aspects of each of the three options were discussed. The Committee requested further information about the protocol for observers at other ministerial advisory committees affected. The Committee requested that the Secretary send an email about this to members for further consideration. Secretary’s note The Committee considered the comments received during consultation. The Committee supported Proposal 1 (no change) with a variation to the protocol for applicants, who instead of attending in person, should make themselves available on the day for questions either by video or teleconference. Implementation of any changes will take place at the 62nd meeting after agreement from the Minister of Health’s delegate. |
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| 10.3 | Therapeutics Products Bill update |
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Medsafe was requested to give an update about the Therapeutics Products Bill update at the previous meeting. Medsafe informed the Committee that there have been no updates since the last meeting. |
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| 10.4 | Feedback to the Secretary |
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The Committee thanked the Secretary for the support provided and gave good feedback about the supporting documentation that was prepared. |
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| 10.5 |
Dr Stewart Jessamine (Chair) announced his resignation from the Medicines Classification Committee |
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Members of the Committee thanked Stewart for his passion and strong commitment to this Committee, and wished him well for his next endeavours. The Secretary will write to the Minister to appoint a new member and Chair. |
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| 11 | Date of the next meeting |
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To be confirmed. |
There being no further business, the Chair thanked members and guests
for their attendance and closed the meeting at 1:50 pm.
This document was prepared and written by Jessica Lo Secretary for the Medicines Classification Committee
