Decision on Schedule changes made in response to COVID-19

Medicines

Decision

What we’re doing

Earlier this year, PHARMAC 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 as a result of shifting to Alert Level 4 in March.

We are now able to announce the longer-term funding arrangements for these pharmaceuticals. For some, this means that the previous criteria will be reinstated; for others, these temporary arrangements will become permanent.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 17 June 2020.

In response to the evolving situation, with the recent change in Alert Levels, we have decided to defer the Schedule changes that were proposed for 1 September 2020. We will continue to monitor the situation and will make decisions on timing as more information becomes available, however we do not intend to make any changes prior to 1 December 2020.

Following consideration of consultation feedback, the proposal was also amended to:

  • maintain a provision in the Special Authority criteria for sacubutril with valsartan for when echocardiography is not reasonably practical;
  • permanently remove the dosing restrictions for pembrolizumab and nivolumab; and
  • continue to allow joint count assessments for adalimumab, etanercept, infliximab and rituximab to be performed remotely.

We are still considering whether to reinstate the previous criteria for pegfilgrastim, and expect to make a decision on this in the coming months. In the interim, the current arrangements will continue.

Who we think will be most interested

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

Detail about this decision

Temporary changes to be reversed

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule. The timing of these changes is still being determined based on current events, however we do not expect to implement these until December at the earliest, and we will give at least a month’s notice prior to the changes being implemented.

Note that changes to Special Authority will only affect new Special Authority applications: any active Special Authority approvals would continue in force, so people would only be affected if and when a Special Authority renewal application was required.

Pharmaceutical

Details

Abiraterone

We will reinstate the requirement for PSA testing as part of renewal applications.

Alglucosidase alfa, betaine, galsulfase, saproterin dihydrochloride and sodium phenylbutyrate

We will reinstate the requirement that renewal applications be submitted by metabolic physicians (rather than any relevant practitioner).

Ambrisentan, iloprost and epoprostenol

We will resume requiring applications to the PAH panel to submit all diagnostic results listed on the application forms.

Bosentan

We will reinstate the requirement that renewal applications be submitted by a respiratory specialist, cardiologist or medical practitioner on the recommendation of a respiratory specialist or cardiologist (rather than any relevant practitioner).

Emtricitabine with tenofovir (PrEP)

We will reinstate a full STI screen as a prerequisite for Special Authority applications.

Erlotinib and gefitinib

We will remove the temporary renewal criteria for use when radiological assessment cannot be undertaken due to health sector constraints.

Everolimus

We will remove the temporary renewal criteria for use when MRI scanning cannot not be undertaken due to health sector constraints.

Glycopyrronium, tiotropium and umeclidinium

We will re-insert the requirement for COPD to be diagnosed using spirometry into the Endorsement criteria for these products.

Hyoscine butylbromide

We will remove criteria that enable hyoscine patches to be used as a substitute for hyoscine injections where access to a syringe driver is affected by health sector constraints.

Insulin pump consumables

We will reinstate the requirement that renewal applications be submitted by relevant specialists or nurse practitioners (rather than any relevant practitioner), and that HbA1c requirements should be assessed based on current (rather than recent) results.

Modafinil

We will remove the temporary criteria for use when sleep latency is not possible due to health system constraints.

Multiple sclerosis treatments

We will resume requiring EDSS assessments to be performed in-person, rather than remotely.

Nintedanib and pirfenidone

We will resume the requirement for multidisciplinary involvement at diagnosis, and requiring renewal applications to be submitted by respiratory specialists (rather than any relevant practitioner).

Octreotide LAR

We will remove the temporary renewal criteria for use when IGF1 testing cannot be undertaken due to health sector constraints.

Pembrolizumab and nivolumab
(see also next section)

We will reinstate the requirement for radiological response as part of renewal applications.

Sildenafil

We will reinstate the requirement for PCWP, PAPm and PVR in Special Authority applications for pulmonary hypertension.

Sunitinib

We will remove the temporary GIST renewal criteria for use when CT scanning cannot be undertaken due to health sector constraints.

Vigabatrin

We will remove the temporary criteria for use when visual field testing cannot be performed due to health system constraints.

Changes made permanent

The following temporary changes will not be reversed and so will become permanent changes.

Pharmaceutical

Details

Pembrolizumab and nivolumab
(see also previous section)

We will not reinstate the maximum dose restriction for these treatments, to continue to allow flexibility of administration.

Sacubitril with valsartan

We will keep a provision that averts the need for an echocardiogram if one is not reasonably practical given health sector resource constraints.

Dornase alfa

We previously removed the need for spirometry in patients over 5 years, specific requirements around where patients are treated and relaxed renewal criteria, and we will maintain these changes.

Adalimumab, etanercept, infliximab and rituximab

We endorsed clinicians performing joint counts by telephone, rather than in person; as this related to how clinicians could interpret the criteria, we are not proposing a Schedule change at this time, and clinicians will continue to have discretion on this matter.

Retail pharmacy – specialist restrictions

We removed the ‘retail pharmacy – specialist’ restriction from 24 pharmaceuticals in April, and we will maintain the removal of these restrictions.

Deferred decision

Pharmaceutical

Details

Pegfilgrastim

We had proposed to return the threshold for risk of febrile neutropenia from back to 20%, having been temporarily reduced to 5%.

Responders provided feedback in support of making this a permanent change. We are now intending to delay making a decision on this matter in order to better understand the financial impact of this temporary change before we make a longer-term decision.

In addition, we received several suggestions in consultation feedback that we will need to seek further advice about from PTAC and/or its Subcommittees before making a decision. These are outlined in the following section.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are set out below:

Theme

Comment

Adalimumab, etanercept, infliximab and rituximab

We received feedback requesting that clinicians continue to be able to perform joint counts remotely, rather than in person, noting that the Special Authority criteria does not specify methods of collecting joint counts, and patients can be taught how to conduct their own joint counts.

Responders also requested that Special Authority approvals for these agents become valid indefinitely for patients who have been stable on treatment for over two years.

We note that while we had endorsed the approach to perform joint counts remotely during Alert Level 4, the Special Authority requirements do not specifically prevent this from happening. However, we consider that the approach to determining joint counts should be undertaken at the discretion of the clinician, when evaluating whether a face to face assessment of a patient’s treatment response is required.

The renewal criteria for these agents in rheumatology indications are consistent with clinical advice received from PTAC and the Rheumatology Subcommittee. A number of factors are taken into consideration when considering the duration of renewal for patients managed on these treatments, including treatment cost and available evidence of treatment efficacy.

Hydroxychloroquine

We received a request to extend the subsidy restriction to include patients with sarcoidosis (pulmonary and non-pulmonary), noting a concern that patients with sarcoidosis may have to either change treatments or cease treatment due to the restrictions.

The current restriction allows pharmacists to annotate prescriptions where there exists a record of prior dispensing of hydroxychloroquine, meaning that all patients treated with hydroxychloroquine (for any indication) prior to introduction of the restrictions are able to continue to access funded treatment.

We will be amending the endorsement criteria to include sarcoidosis, to enable new patients to commence treatment.

Modafinil

We received a request to permanently remove the requirement for a sleep latency test, given the difficulties in accessing this service for children.

We will be reinstating this requirement for now, but we will engage with our clinical advisors on this issue at the next opportunity.

Pegfilgrastim

We received requests to retain the new criteria for access to pegfilgrastim, which would improve quality of life of patients and result in fewer patients requiring hospital stays for treatment febrile neutropenia.

We will continue the temporary arrangements for the next few months. This will enable us to better evaluate the financial impact of the change before making a longer-term decision, which we expect to be able to make before the end of the year.

Pembrolizumab and nivolumab

Feedback suggested support for reinstating the requirement for radiological monitoring.

Responders requested that we retain the removal of restrictions on maximum dose, to allow for clinician and patient choice of dosing schedule and provision for extended flat dosing schedules and associated reduced resource utilisation including from infusion frequency, clinic visits and monitoring.

Following consideration of consultation feedback, we are not reinserting the dose cap criterion. We note that allowing flexibility in dosing schedules will be of benefit to both patients and the health system.

Emtricitabine with tenofovir (PrEP)

Responders support the requirement of a full STI screen. However, some considered that the Special Authority should only require that an STI screen is ordered at the time of prescribing, with patients instructed to fill the prescription once informed it is safe to do so.

Following consideration of the consultation feedback, PHARMAC consider it appropriate to revert back to the criteria that required full STI screen.

We note the additional feedback regarding the timing of the STI screen relative to prescribing. We intend to seek further advice on this from Anti-Infective Subcommittee at its next meeting.

Glycopyrronium, tiotropium and umeclidinium

We received requests to retain the new endorsement criteria for access to these long-acting muscarinic agonists.

Responders considered that clinicians had become comfortable with the use of these products since they were listed and that the requirement for spirometry was presenting an unnecessary inequitable barrier to treatment.

Following consideration of consultation feedback, we consider that it is appropriate to revert back to the criteria that required COPD diagnosis via spirometry.

When the decision was made to make this temporary change, advice from our Respiratory Subcommittee was that this should only be temporary as the diagnosis of COPD requires spirometry. The Subcommittee considered that, due to the circumstances during lockdown, clinician judgement was appropriate for diagnosis decisions.

Sacubitril with valsartan

We received feedback requesting that the requirement for echocardiogram not be reinstated at this time, noting that reinstatement of the requirement may lead to a geographical inequity.

Following consideration of consultation feedback, we will keep this provision in place permanently.

Retail pharmacy – specialist

Some responders supported the permanent removal of the ‘retail pharmacy – specialist’ restriction, noting that may help to streamline access to treatments, rather than increase the use of them.

Feedback noted that prescribers are generally wary about prescribing agents that they are not familiar with.

We note that our experience to date is also that removal of this restriction leads to changes in how care is provided, but not necessarily an increase in prescribing overall.

We agree that prescribers are in a good position to decide whether or not prescribing these agents fits within their scope of practice and level of expertise.

Retail pharmacy – specialist (antimicrobial agents)

We received feedback concerned about the risk of inappropriate prescribing of antimicrobial agents in absence of any schedule restrictions, with some responders requesting that the previous restrictions be reinstated.

Some responders suggested that indication-based restrictions could be used instead (or in preference) in order to ensure good prescribing behaviour.

We note that our preference, when using funding criteria, is to target the specific indication, rather than the prescriber.

We note that for some of these products there may be a need for indication-based restrictions (Special Authority or endorsement) to be implemented; we intend to seek further advice on this matter from the Anti-Infective Subcommittee.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.