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

Source: Pharmac

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

Change	Proposal
Alimentary Tract and Metabolism therapeutic group
Insulin pump consumables We enabled any relevant practitioner to be able to submit renewal applications (we previously required applications be from relevant specialists or nurse practitioners). We also included a provision to enable HbA1c requirements for renewal applications to be based on recent results, rather than current results.	We are proposing to revert to the normal criteria from 1 September 2020
Alglucosidase alfa, betaine, galsulfase, saproterin dihydrochloride and sodium phenylbutyrate The criteria for these pharmaceuticals were amended to allow any relevant practitioner to submit renewal applications (we previously required applications from metabolic physicians)	We are proposing to revert to the normal criteria from 1 September 2020
Hyoscine butylbromide We widened access to hyoscine patches to enable their use as a substitute for hyoscine injections where access to a syringe driver was affected by current constraints on the health sector	We are proposing to revert to the normal criteria from 1 December 2020
Cardiovascular System therapeutic group
Bosentan The criteria were amended to allow any relevant practitioner to submit renewal applications (we previously required a respiratory specialist, cardiologist or medical practitioner on the recommendation of a respiratory specialist or cardiologist)	We are proposing to revert to the normal criteria from 1 September 2020
Sildenafil We waived the need for PCWP, PAPm, or PVR in pulmonary hypertension if these were not possible due to sector capacity constraints	We are proposing to revert to the normal criteria from 1 December 2020
Ambrisentan, iloprost and epoprostenol We have been considering applications to the PAH panel for these treatments whether or not applicants are able to submit all required diagnostic results	We are proposing to revert to the normal criteria from 1 December 2020
Sacubitril with valsartan We removed the requirement for an echocardiogram if this was not reasonably practical, given health sector resource constraints	We are proposing to revert to the normal criteria from 1 December 2020
Infections therapeutic group
Emtricitabine with tenofovir (PrEP) We suspended the need for a full STI screen every three months	We are proposing to revert to the normal criteria from 1 September 2020
Respiratory System and Allergies therapeutic group
Nintedanib and pirfenidone We removed the requirement for multidisciplinary involvement at diagnosis, and enabled any relevant practitioner to submit renewal applications (we previously required these from respiratory specialists)	We are proposing to revert to the normal criteria from 1 September 2020
Dornase alfa We removed the need for spirometry in patients over 5 years, specific requirements around where patients are treated and relaxed renewal criteria	We are not proposing to reverse these changes at this point in time
Glycopyrronium, tiotropium and umeclidinium We removed the requirement for COPD to be diagnosed using spirometry	We are proposing to revert to the normal criteria from 1 December 2020
Nervous System therapeutic group
Multiple sclerosis treatments We allowed EDSS assessments to be performed remotely while outpatient appointments were being limited	We are proposing to revert to the normal criteria from 1 September 2020
Modafinil We waived the need for sleep latency testing if this was not possible due to current system constraints	We are proposing to revert to the normal criteria from 1 December 2020
Vigabatrin We waived the need for visual field testing if this was not possible due to current system constraints	We are proposing to revert to the normal criteria from 1 December 2020
Oncology Agents and Immunosuppressants therapeutic group
Adalimumab, etanercept, infliximab and rituximab We have endorsed clinicians performing joint counts by telephone, rather than in person	We are proposing to revert to the normal criteria from 1 September 2020
Pembrolizumab and nivolumab We removed the maximum dose restriction, as well as the requirement for radiologic response	We are proposing to revert to the normal criteria from 1 December 2020
Everolimus We introduced new renewal criteria for use when MRI scanning could not be undertaken due to current health sector constraints	We are proposing to revert to the normal criteria from 1 December 2020
Abiraterone We removed the requirement for PSA testing as part of renewal applications	We are proposing to revert to the normal criteria from 1 September 2020
Erlotinib and gefitinib We introduced new renewal criteria for use when radiological assessment could not be undertaken due to current health sector constraints	We are proposing to revert to the normal criteria from 1 December 2020
Sunitinib We introduced new GIST renewal criteria for use when CT scanning could not be undertaken due to current health sector constraints	We are proposing to revert to the normal criteria from 1 December 2020
Octreotide LAR We introduced new acromegaly renewal criteria for use when IGF1 testing could not be undertaken due to current health sector constraints	We are proposing to revert to the normal criteria from 1 September 2020
Pegfilgrastim We amended the threshold for risk of febrile neutropenia from 20% to 5%	We are proposing to revert to the normal criteria 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. 

MIL OSI