Decision on Schedule changes made in response to COVID-19

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.