Hospital pharmaceuticals: Schedule rules and policy changes

There are two parts to this proposal:

• Part A: Schedule rules for hospital pharmaceuticals
• Part B: Named Patient Pharmaceutical Assessment (NPPA) policy changes

A brief overview of the proposals is provided on the following page, and you can find more information in the two attachments (Attachment One: Schedule Rules for Hospital Pharmaceuticals, and Attachment Two: NPPA policy changes).

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 5 April 2013 to us at hospital.pharmaceuticals@pharmac.govt.nz

We are interested in your feedback on any part of this proposal. In relation to the NPPA changes, we have outlined particular questions that we would appreciate your feedback on. These can be found on page 3 of attachment two.

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.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do. 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 withheld.

If you would like to arrange a time for a meeting or teleconference to discuss elements of this proposal with us, please let us know.

Other information

Previous consultation documents relating to this work, as well as notifications of decisions can be found on our website. [link no longer available]

Proposal overview

• Part II of Section H of the Pharmaceutical Schedule (the “hospital medicines list”) would include all of the medicines that must be funded in DHB hospitals.
• In general, the hospital medicines list would be binding, and DHBs would not be able to prescribe unlisted medicines, unless they are out of scope; an exemption applies; or approval has been granted through the Named Patient Pharmaceutical Assessment (NPPA) process.
• Some medicines currently used by DHB hospitals do not fall within the scope of the hospital medicines list, and DHBs would still be able to prescribe them, subject to any national contracts that may be in place (see page one of attachment one for more detail).
• Exemptions would also apply in the following circumstances (see page three of attachment one for more detail):
  • DHB hospitals would be able to use medicines as part of a clinical trial, as long as funding is provided as part of that trial.
  • Patients who have been stablised on treatment prior to 1 July 2013 would be able to continue treatment.
  • DHB hospitals would be able to continue to supply an unfunded medicine for an inpatient, if that patient’s own supplies were unavailable.
  • The exemption that applies to the use of pharmaceutical cancer treatments (PCTs) would continue for now. We are reviewing this exemption, but are not proposing to remove it from 1 July 2013.
  • PHARMAC would be able to allow the use of a medicine in a DHB hospital, if doing so would help us assess whether that medicine should be included in the hospital medicines list.
• DHB hospitals would also be able to dispense any hospital medicine to a patient for use in the community. This allowance is currently limited to a small number of medicines.
• There would be some prescribing restrictions for some hospital medicines:
  • Some hospital medicines would have indication-based restrictions, which would mean the medicine could only be prescribed for certain indications.
  • Some hospital medicines would have prescriber-based restrictions. Other prescribers would still be able to prescribe the medicine if they have the recommendation of the specified prescriber, or if doing so is in accordance with a protocol approved by the DHB. DHBs would be able to determine how best to ensure these restrictions are adhered to, and would also have the ability to implement their own prescriber-based restrictions, if they considered that doing so is necessary to ensure good clinical practice (but not solely for cost reasons).
• DHB hospitals would also be able to seek approval for unlisted medicines for individual patients under the NPPA policy. We are proposing a number of changes to the NPPA policy, to enable the policy to manage both hospital and community exceptions (see attachment two for more detail).
  • We are proposing to remove the Hospital Pharmaceuticals in the Community (HPC) NPPA pathway. The proposed Schedule rules would allow DHB hospitals to administer medicines from the hospital medicines list in either the community or the hospital, making the HPC pathway unnecessary (refer to page one of attachment two for more detail).
  • We are proposing to include an alternative assessment process for NPPA applications that are particularly urgent. This process allows the DHB to make decisions on funding, when it is not feasible for PHARMAC to consider the application in a clinically appropriate time frame (refer to page one of attachment two for more detail).