Proposal relating to Schedule changes made in response to COVID-19

What we’re proposing

Over the last few months, PHARMAC has amended or removed funding criteria for many pharmaceuticals in order to help improve access to these treatments in anticipation of and/or response to COVID-19 impacts on the health sector. 

We are now working to determine the longer-term funding arrangements for these pharmaceuticals, and are seeking feedback from stakeholders on: 

1. a proposal to maintain these changes for some products indefinitely, and 
2. a timeline for resumption of previous criteria for other products. 

Consultation closes at 5 pm on Friday 3 July 2020 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

If the proposal is accepted, the criteria changes would affect new Special Authority applications. Any active Special Authority approvals would continue in force, and would only be affected if and when a Special Authority renewal application was required. 

Who we think will be interested

• Prescribers
• DHB hospital service managers
• Community and hospital pharmacists
• Patients and their whānau 

About these changes

When New Zealand entered Alert Level 4, to stem the spread of COVID-19 infection, we received numerous requests from across the health sector to temporarily modify the funding arrangements for specific pharmaceuticals. We started implementing these changes in late March and have continued making further adjustments, as recently as June. These changes were intended to better reflect the unique constraints that the health sector was experiencing, as well as to prepare for a potential surge in demand for hospital services. The nature of these changes were, broadly: 

• Making it easier for clinicians to initiate (or continue) funded treatment independently 
• Suspending the need for specific diagnostic procedures that could not be reasonably accessed 
• Other changes to facilitate providing care for patients away from hospitals

As we shift to lower Alert Levels, the health sector will be going through the process of returning to normal service levels, although we are aware that a backlog of cases will mean that this transition will take some time.

Details about our proposal

Hydroxychloroquine

We added the following endorsement criteria to the funding of hydroxychloroquine at the end of March (subsequently amended in May), in order to avoid an out-of-stock event that would be harmful to existing patients: 

Subsidised only if prescribed for rheumatoid arthritis, systemic or discoid lupus erythematosus, malaria treatment or suppression and the prescription is endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of hydroxychloroquine. 

In the week prior to implementing these new criteria, prescribing of hydroxychloroquine had more than doubled from its long-term average. We note that the utility of hydroxychloroquine as a treatment for COVID-19 is unproven, and widespread prescribing for this would likely cause stock to be depleted at the expense of other patients. 

While we do not intend for this restriction to be in place indefinitely, we are proposing to maintain the endorsement criteria for the time being, and at least until the end of this year.

Changes to Special Authority and endorsement requirements

Our proposed approach to the temporary Special Authority and endorsement changes is broadly that: 

• Temporary criteria changes relating to specialist consultations and laboratory testing would be reversed from 1 September 2020 

• Temporary criteria changes relating to radiology and other hospital-based diagnostic procedures would be reversed from 1 December 2020

Specialist recommendations

In April, we removed the ‘Retail Pharmacy – Specialist’ restriction from a number of community pharmaceuticals. This restricting requires that a prescription be written by, or on the recommendation of, a particular ‘specialist’ (as defined in the Pharmaceutical Schedule) in order to be subsidised. In a small number of cases, the restriction is used as an override to some other constraint (such as a dose restriction). 

Although the definition of ‘specialist’ in the Pharmaceutical Schedule had once been more narrowly defined, it now encompasses all vocationally registered medical practitioners. That being the case, the restriction still creates issues for many other prescriber groups, such as nurse practitioners and pharmacist prescribers, as well as non-vocationally registered GPs, and is not in keeping with allowing the prescribing health workforce to practice at the top of  their respective scopes. 

We are proposing to make the removal of this restriction from these pharmaceuticals permanent, which are detailed below. 

In the Blood and Blood-Forming Organs therapeutic group:

• Total parenteral nutrition (TPN)

In the Cardiovascular System therapeutic group:

• Amiodarone hydrochloride (100 mg and 200 mg tablets)
• Flecainide acetate
• Propafenone hydrochloride

In the Hormone Preparations therapeutic group:

• Cyproterone acetate
• Desmopressin acetate (nasal drops and nasal spray)
• Dexamethasone
• Medroxyprogesterone acetate (100 mg tablets)
• Methylprednisolone
• Methylprednisolone (as sodium succinate)
• Metyrapone
• Testosterone cipionate
• Testosterone undecanoate
• Testosterone esters

In the Infections therapeutic group:

• Fluconazole
• Clindamycin
• Sodium fusidate (fusidic acid)
• Ketoconazole (200 mg tablets)

In the Oncology Agents and Immunosuppressants therapeutic group:

• Azathioprine
• Interferon alfa-2a
• Flutamide
• Megestrol acetate

In the Various therapeutic group:

• Acetylcysteine

Note that removing the ‘Retail Pharmacy – Specialist’ restriction from some of these products had the consequential effect of removing some other restrictions, as the specialist endorsement was required to override those constraints: 

• In the case of fluconazole 150 mg capsules, we have also removed both the 1 capsule per prescription limit, and the following endorsement criteria: 

Patient has vaginal candida albicans and the practitioner considers that a topical imidazole (used intra-vaginally) is not recommended and the prescription is endorsed accordingly. 

• In the case of clindamycin 150 mg capsules, we have also removed the 4 capsules per prescription limit 

• In the case of itraconazole 100 mg capsules, we have also removed the following endorsement criteria: 

Funded for tinea vesicolor where topical treatment has not been successful and diagnosis has been confirmed by mycology, or for tinea unguium where terbinafine has not been successful in eradication or the patient is intolerant to terbinafine and diagnosis has been confirmed by mycology and the prescription is endorsed accordingly. 

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on Friday, 3 July 2020. 

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal. 

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request. 

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.