Committees

Published: 9 August 2018

Agenda for the 61st meeting of the Medicines Classification Committee to be held in Wellington on Friday 2 November 2018 at 9:30 am

1

WELCOME

2

Apologies

3

Confirmation of the minutes of the 60th meeting held on 26 APRIL 2018

4

Declaration of conflicts of interest

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.


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.

5.2

Update on outstanding agenda items from the 60th meeting

(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.

5.3

Referred submission from the 60th meeting – agenda item 6.4 melatonin – proposed reclassification from prescription medicine to a restricted medicine

The Committee recommended that Medsafe should consult again on the reclassification of melatonin to a restricted medicine because the published agenda 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.

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)

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.

6.2

Dextromethorphan, opium tincture, squill oxymel and pholcodine – proposed reclassification from general sale and pharmacy only medicines to restricted medicines
(Medsafe)

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

7

New medicines for classification

7.1

Linaclotide

Constella capsule, 72, 145 and 290 micrograms (TT50-10362, a, b)

7.2

Ribociclib succinate

KISQALI film coated tablet, 200 mg (TT50-10426)

7.3

Risankizumab

TRADENAME (risankizumab) solution for injection, 90 mg/mL (TT50-10443)

7.4

Benralizumab

Fasenra solution for injection, 30 mg/mL (TT50 number to be confirmed)

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.

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)


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.

8.1.2

Baricitinib (November 2017)


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.

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.

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.

8.1.5

Daratumumab (May 2018)


Daratumumab is indicated for use:
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.- as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent.

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.

8.1.6

Durvalumab (May 2018)


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.

8.1.7

Inotuzumab ozogamicin (May 2018)


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.

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.

8.1.9

Lonoctocog alfa (May 2018)


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.

8.1.10

Midostaurin (May 2018)


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.

8.1.11

Neratinib (May 2018)


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.

8.1.12

Obeticholic acid (May 2018)


Obeticholic acid is indicated for the treatment of primary biliary cirrhosis.

From June 2018, obeticholic acid is classified as a prescription medicine in Australia.

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.

8.1.14

Tezacaftor (November 2017)


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.

8.1.15

Voxilaprevir (November 2017)


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.

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

8.2.1a

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.

8.2.1b

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.

8.2.1c

Melatonan II


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.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting