Summary of submissions - NPPA policy review
This is a summary of submissions from stakeholders who responded to PHARMAC’s consultation document PHARMAC’s Review of the Named Patient Pharmaceutical Assessment Policy (NPPA) via either direct submission to PHARMAC and/or attendance at a half-day Consultation Event.
PHARMAC is reviewing the NPPA Policy as part of our rolling review of our Operating Policies and Procedures (OPP). The NPPA Policy has been in place now for two years, and during this time has been updated to manage hospital medicines. We felt it timely to seek feedback on the NPPA policy to assess if it is achieving the objectives we set out to achieve when we established the policy, and if there are any changes that should be made.
PHARMAC released the consultation document on 8 April 2014 on the PHARMAC website, and the consultation period ran until 2 May 2014. Written submissions were received from 39 submitters. The table below provides a breakdown of the submitter type. 23 public submitters provided a submission supporting the submission of a consumer group.
|Submitter type||No. of submissions|
PHARMAC also held a half-day Consultation Event on Wednesday 15 April, which was open to the general public, with the NPPA policy review being one of the three agenda items. 80 people attended this forum.
Structure of the summary
PHARMAC’s Review of the Named Patient Pharmaceutical Assessment Policy (NPPA) consultation document included three consultation questions intended to prompt submitters’ thinking on the proposed changes, and so this summary is structured according to these questions. For those submissions where general commentary was provided (instead of answering the questions or in addition to), and where the feedback was received at the Stakeholder Event, this has been incorporated under the most relevant question. A number of submitters specifically provided feedback on the NPPA application process, and on individual decisions. An additional section has been incorporated into the Summary to reflect this feedback.
1. Have we achieved the objectives we set out to achieve when we implemented NPPA? Why or why not?
Three submitters, including two clinicians and a professional association, felt that the current NPPA policy is achieving the objectives PHARMAC set out to achieve. Another professional association felt the UA pathway was working well; however expressed confusion around the UCC pathway and felt the prerequisites in particular could be expressed more clearly. A couple of attendees at the Stakeholder Event questioned the purpose of the NPPA review given it is working effectively.
Other submitters did not feel the NPPA policy was achieving its objectives. One clinician felt the NPPA process has ended up rationing pharmaceuticals but not on rational grounds. Three submitters felt the NPPA policy specifically failed in relation to considering orphan medicines and people with rare conditions. One of these submitters felt PHARMAC had not provided enough information in the consultation material to tell if the approved applications were genuine exceptional circumstances and therefore if the policy was achieving its objectives. Another of these submitters felt that although it had achieved in respect of shifting some medicines from NPPA to the Pharmaceutical Schedule, it had failed in enabling more specialised medicines for rare disorders. This view was also supported by a number of attendees at the Stakeholder Event.
A consumer group, with letters of support from 23 member of the public, felt the current policy is not working due to the confusing wording and narrow prerequisites, with the outcome being too few applications being assessed.
2. 33% of NPPA applicants since 1 March 2013 weren’t considered against the nine decision criteria because they didn’t meet the prerequisites or because we didn’t hear back from the applicant. What does this say about the prerequisites? Are they confusing? Do they need to be made specific or clearer? If so, how?
The eight submitters that responded specifically to this question, raised concerns about the current prerequisites, with many noting the prerequisites are too narrow.
Two submitters, including a member of the public and a professional association, felt that the data provided by PHARMAC (33% of applications not meeting prerequisites or due to PHARMAC not hearing back from the applicant) was not clear. These submitters felt a further breakdown of how many within this percentage did not meet the prerequisites, which prerequisites, and how many were non-follow ups would be give a better indication on what this says about the prerequisites. One of these submitters (a member of the public) noted that the prerequisites are not poorly worded, but disagrees with the intent of the prerequisites and PHARMAC’s application of them.
Two submitters (a clinician and a professional association) thought the prerequisites under the UCC pathway were particularly confusing and needed to be better defined. The clinician noted that entry to the UCC pathway should not rely on the prescriber or applicant having a reasonable understanding of PHARMAC’s work.
Two submitters (both consumer groups) questioned the prerequisite of the treatment not having been already considered through the Schedule decision making process, for the patient’s clinical circumstances. One of these submitters felt PHARMAC’s rationale of protecting the Schedule was not a reasonable enough justification for this prerequisite. The other submitter also referenced the Ombudsman’s comments around the need for PHARMAC to build in an external element into its decision making process.
Two submitters, including a clinician and a consumer group, felt the expectation that a patient will not be part of a wider patient group is too narrow an interpretation of both the legislative provision relating to ‘exceptional circumstances’ and the term ‘unusual clinical circumstances.’ The consumer group submitter felt the emphasis on ‘individual only’ did not acknowledge that very small groups of people with rare conditions may have very specific needs. This submitter noted the contradiction between PHARMAC’s assertion that rare disorders need not be treated differently, and the proposed Request for Proposals specifically for medicines for rare disorders to be released by PHARMAC later this year. Another submitter (a member of the public) also felt the prerequisites in general were too narrow to adequately assess the needs of patients with rare conditions.
A member of the public also felt the prerequisite that the patient must have tried all existing funded treatments available was cruel, in requiring patients to undertake lengthy and unnecessary treatment trials to prove they have ticked all the “red tape boxes.” This submitter felt this prerequisite was a substantive waste of clinician time and resulted in additional costs to the system.
A consumer group felt that prerequisites are unnecessarily restrictive given PHARMAC has the general discretion to consider applications that do not meet the prerequisites, and thus should be shifted to a lower level of status.
3. What circumstances or areas of unmet need does the NPPA policy not currently address?
Three submitters (a professional association and two members of the public) responded specifically to this question and all felt that people with rare conditions are unfairly disadvantaged through the NPPA policy. This view was supported by some attendees at the Stakeholder Event. Submitters felt the current process does not take into account for example the economic realities associated with the development of these medicines. One of these submitters felt the policy should be changed to prioritised life-saving medicines.
4. Other comments
Nine submitters (including seven clinicians, a consumer group and a professional association) all commented on issues with the NPPA process and/or made recommendations for improvement:
- The NPPA application form and information on the website is difficult to access and there is a lack of clarity around which forms to access for what.
- Application is long, overly complex and consequently extremely time consuming for clinicians.
- There should be a time-frame provided when feedback can be expected, and this should be under three days where possible. An acknowledgement email should be sent upon receipt of application.
- There is a lack of clarity around the reason for decline. Some attendees at the Stakeholder Event also raised concern about the lack of communication with the patient following decisions.
- The forms should be electronic, and for frequent NPPA applications it would be useful to have a template that was pre-populated.
- Would be helpful to be able to view a summary of previous NPPA applications to see which have been approved or declined.
- Clinicians should not be expected to know the cost of various medicines.
- For Special Authority exceptions there should be an additional tick-box on the Special Authority applications form, rather than a requirement to fill in the entire NPPA form.
- Would be preferable that PHARMAC undertake ‘rapid assessment’ where possible.
- A simplified form for re-applications should be available where the submitter is required only to provide information on whether the drug has been valuable, with a focus on efficacy and adverse events.
- Recommend implementing a ‘high-trust, low-bureaucracy special exceptional authority’ for GPs to apply through when patients do not quite meet the Special Authority criteria.
b. Individual decisions
A number of submitters used examples of individual treatments which they felt the NPPA policy was insufficient in terms of patients not getting access to the treatment:
- intrauterine levonorgestrel delivery system (Mirena);
- varenicline tartrate (Champix);
- lysosymal enzymes.
Last updated: 24 February 2016