Decision relating to various oncology medicines
PHARMAC is pleased to announce the approval of proposals for various oncology pharmaceuticals, including new listings and amendments to funding restrictions, to take effect from 1 July 2017.
The proposal was approved as consulted on except for a delay in the implementation date for the thalidomide claiming category change. This change will take effect on 1 August 2017 to allow the claiming process changes to be communicated with the sector and enable a transition plan to be developed for any patients with part scripts already dispensed.
In summary, the effect of the decision is that:
- Erlotinib (Tarceva) and gefitinib (Iressa) funding criteria will be widened to permit patients with non-small cell lung cancer to switch between treatments at any time due to intolerance.
- Nivolumab (Opdivo) and pembrolizumab (Keytruda) funding criteria for treatment of patients with advanced melanoma will be amended to add a requirement for patients to have an ECOG performance status score of 0-2.
- A new 15 mg capsule strength of lenalidomide (Revlimid) will be listed from 1 July 2017.
- Thalidomide (Thalomid) claiming category will be changed from “PCT only” to “Retail pharmacy” from 1 August 2017.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 26 May 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:
|One responder requested that the wastage rule be applied to erlotinib and gefitinib.||PHARMAC considers that due to the dosing and pack sizes of erlotinib and gefitinib, wastage is not likely to be a significant issue.|
|One responder was opposed to the proposal for nivolumab and pembrolizumab as they considered there is a lack of evidence showing that patients with performance status above 2 would not benefit from treatment.||PHARMAC staff note that the current available evidence for the use of pembrolizumab and nivolumab in the treatment of advanced melanoma is in patients with good performance status (ECOG 0-1).Should new evidence become available which supports that PD-1 inhibitor treatment for patients with advanced melanoma and an ECOG greater than 2, then PHARMAC could revisit this criterion.|
|One responder was concerned about additional charges for patients associated with community pharmacy dispensing of thalidomide.||A patient co-payment would apply to thalidomide as for other medications dispensed in community pharmacy. This proposal aligns with the government health priority of providing care closer to patients’ homes as patients would be able to have thalidomide dispensed from the community pharmacy alongside other treatments rather than needing to return to the hospital to collect their medication, or receive their medication via postal service.|
|One responder was concerned there may be delays for thalidomide patients while community pharmacies, who are not already enrolled in the Celgene i-access® programme, complete registration and training requirements.||PHARMAC notes most hospital pharmacies or hospital-associated retail pharmacies are likely to be enrolled and patients could continue to access thalidomide from these pharmacies if alternative more convenient community pharmacy locations are not available. In time, the decision is likely to provide greater choice for patients about where they collect their thalidomide. We have delayed the implementation date for the change to 1 August 2017 and we are working with the supplier of thalidomide, Celgene, to ensure the changes are communicated to prescribers and pharmacy. PHARMAC will also communicate with hospital pharmacies about the options for claiming thalidomide after 1 August 2017 for any patients who have repeats remaining on their prescriptions, and whose initial dispensing was claimed as a PCT.|
|Concern regarding the impact on pharmacy and request for a higher handling fee for the additional administrative tasks associated with each dispensing of thalidomide.||PHARMAC staff note enrolment in the i-access® programme is voluntary, hence pharmacies that do not wish to be involved are not compelled to do so.PHARMAC is not responsible for setting dispensing or service fees payable to pharmacy and notes that thalidomide dispensing requirements will be similar to lenalidomide, for which we understand there are no such arrangements in place.|
|Requests that the wastage rule be applied to thalidomide.||PHARMAC notes that wastage currently applies to lenalidomide because dosage reductions, potentially requiring part-packs to be dispensed, are sometimes required. However, with thalidomide, the recommended daily dosage is 50-200 mg which can be given as multiples of the 50 mg capsules. The 100 mg capsules are listed in the Schedule, but are not currently being used. Most patients on thalidomide would be prescribed in monthly or 28 day amounts (with or without repeats). If the product was prescribed as 30 days supply, PHARMAC consider it reasonable for the pharmacy to ensure the dispensed quantity is reduced to multiples of 28 accordingly to eliminate wastage.In the 2016 financial year, almost all scripts dispensed and PCT claimed were in quantities divisible by the manufactures pack size of 28 capsules.We therefore consider it unlikely that pharmacies would be left with unsold part packs. If it becomes an issue for community pharmacies PHARMAC could reconsider the application of the wastage rule at a later stage.|
|Requests listing of the 5 mg strength of lenalidomide to facilitate dose reductions and reduce wastage.||This proposal would not prevent PHARMAC from considering a 5 mg strength of lenalidomide for listing at a later stage, should an acceptable commercial proposal be received.|
If you have any questions about this decision, you can email us at email@example.com or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.