Consultation on proposed 2021/22 Invitation to Tender: For patients

• A proposal to tender certain medicines for principal supply;
• The implications of awarding Principal Supply Status (PSS); and
• The draft process and terms and conditions for the 2021/22 Invitation to Tender (2021/22 Tender).

Demand for medicines we fund, and for new and innovative medicines, is always increasing. Pharmac’s Annual Tender is key in making sure we’re able to keep up with that demand. Pharmac releases the draft Invitation to Tender each year at this time to consult on products which may be included in the Annual Tender. The Annual Tender is invaluable in ensuring we secure medicines (and some medical devices) for New Zealanders, manage spending on medicines and make sure the medicines we fund through the Tender are suitable for people to use.

The consultation on the draft 2021/22 Invitation to Tender is the first step in this process and is a chance for our stakeholders to provide feedback on the proposed products that could be included in the Annual Tender process. Pharmac welcomes all feedback on the draft 2021/22 Tender. Feedback received by the deadline may be considered by the Tender Medical Evaluation Subcommittee of PTAC and would be considered by the Pharmac Board (or its Delegate, where applicable) prior to making a decision on this proposal.

Background

Since 1997 Pharmac has been using the strategy of tendering pharmaceuticals for sole supply of pharmaceuticals for a fixed period of time. Regular tendering has proven to be an effective way to encourage competition among suppliers of pharmaceuticals. As in the past, the community and hospital tender processes would be run in unison, however, the pharmaceutical list for community and hospital supply may be different.

We are seeking feedback on the approach outlined in the following pages, in particular on:

• The proposed tender process and timeline;
• The actual or potential clinical implications of awarding PSS to the medicines listed in Schedule Two, particularly the impact of a brand change on patients, their families and whānau;
• Your views on which medicines included in Schedule Two (or associated medical conditions) might have a particular need for funding of an alternative brand, and what the criteria for funding an alternative brand should be; and
• Your views on whether any product included in Schedule Two might have more than 5% of patients needing to access an alternative brand.

Feedback should be provided by submitting an email to the Tender Analysts:

Email: tender@pharmac.govt.nz

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. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. 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 it withheld. PHARMAC will give due consideration to any such request.

Distribution of consultation documents

Although this consultation letter has been widely distributed, should you consider that a particular person, group or agency should receive this letter and/or future tender documents, please feel free to contact Pharmac or refer it on directly. All tender documents and consultations are also available from the Pharmac website. We also invite any person or group to contact Pharmac should you wish to meet to discuss the proposals contained in this consultation letter.

Details of the proposed 2021/22 Tender

In accordance with Pharmac’s objective (to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided), Pharmac is consulting on a proposal to tender certain pharmaceuticals for Principal Supply Status (PSS) to community pharmacies and/or DHB hospital pharmacies.

Schedule Two is a list of pharmaceuticals that we are considering tendering for Principal Supply Status. [XLSX, 32 KB]

Pharmaceuticals are sorted into therapeutic groups and then listed alphabetically in each group by chemical, form and strength. Each pharmaceutical has a ‘C’ and/or ‘H’ next to it to indicate whether it is proposed to be tendered for community and/or hospital supply.

In general, the proposed 2021/22 Tender process would be similar to the 2020/21 Tender in that the 2021/22 Tender would result in awarding Principal Supply Status instead of Sole Supply Status or Hospital Supply Status.

Download the 2021/22 draft Invitation to Tender [PDF, 601 KB]

Key Aspects of Principal Supply Status

• PSS can apply across community and/or hospital markets (as detailed in Schedule Two).
• The tender winning brand will be the only brand subsidised in the community and/or purchased by DHB hospitals (subject to any alternative brand allowance) for up to approximately 3 years. The PSS period will conclude on 30 June 2025 for all Tenders awarded from the 2021/22 Tender.
• Other brands can continue to be marketed, sold and dispensed during the PSS period, but they would not necessarily receive a subsidy in the community.
• Any pharmaceutical that currently carries a manufacturer’s surcharge in Section B (that is, the additional patient charge above that of the patient co-payment) would become fully subsidised if a tender was awarded for that pharmaceutical.

Alternative brands

• The shift to PSS that we implemented in the previous Tender enables Pharmac greater flexibility to fund alternative brands for those who may experience, or are at heightened risk of, adverse clinical outcomes as a result of a brand change.
• DHB hospitals continue to be able to purchase alternative brands up to a certain percent of volume, similar to the Discretionary Variance provisions of Hospital Supply Status.
• PSS allows Pharmac the flexibility to fund alternative brands in the community:
  • In some cases, this would be through listing (or maintaining the listing of) other brands under Special Authority criteria.
  • In others, we would manage case-by-case approvals through our exceptional circumstances framework.
  • Regardless of the mechanism used, we intend to develop and communicate clear clinical criteria for funding of alternative brands.

• Brand changes are generally well-tolerated, and we expect that the need for funding of alternative brands will vary by product and will not always be predictable. With that in mind, we are interested in receiving feedback on:
  • Which chemicals (or indications for a chemical) or patient groups might have particular need for funding of an alternative brand (and why), and
  • For those situations, whether you consider that clinical destabilisation can be objectively determined, and if so, how.

• The draft contractual terms for the 2021/22 Tender do not put a cap on the number of patients for whom Pharmac might fund an alternative brand, however the draft contractual terms include a threshold (indicated by the “ABA Limit” in Schedule Two) above which suppliers would be reimbursed for lost market share. Accordingly, we are interested to understand if you consider that there are any products that we are proposing to tender where more than 5% of patients might need access to an alternative brand.
• Note that although PSS would give Pharmac the option to fund alternative brands, continued supply of a particular alternative brand cannot always be guaranteed.

Key dates and timeframes for the 2021/22 Tender

The proposed timelines for the 2021/22 Tender are as follows:

Contractual obligations for suppliers

A copy of the draft terms and conditions which would form the terms of the 2021/22 Tender contract is in the draft Invitation to Tender document linked above.

Additional Special Terms

Intra-uterine copper devices

Additional Special Terms have been included in the draft 2021/22 Tender contract for intra-uterine copper devices (Schedule Seven). This clause requires any potential suppliers to offer education, training and support resources to patients and healthcare professionals. This clause also outlines the additional information suppliers must provide relating to their Tender Bid. The full Additional Special Terms for intra-uterine copper devices can be found in the draft 2021/22 Tender contract on the Pharmac website.

Long-acting filgrastim

Long-acting filgrastim has been included in the draft 2021/22 Tender. Pharmac would consider bids for any long-acting filgrastim product (e.g. pegfilgrastim, pegfilgrastim biosimilars, and lipegfilgrastim) for this market; all of which would be subject to the same access criteria. 

A decision on whether to revert to the 20% threshold was deferred in August 2020.

A decision on whether to maintain or amend the access criteria is expected to be made over the coming months subject to clinical advice. Pharmac reserves the right to award the tender to one long-acting filgrastim product for the entire market.

Unresolved Tender Bids

We intend to review any unresolved Tender Bids from the 2018/19 ITT, 2019/20 ITT and 2020/21 Tenders prior to issuing the 2021/22 Tender.  The following Tender Bids remain unresolved:

2018/19 Invitation to Tender

2019/20 Invitation to Tender

2020/21 Invitation to Tender

Should any unresolved Tender Bids be declined prior to the release of the 2021/22 Tender, Pharmac would consider re-tendering those pharmaceuticals when the 2021/22 Tender is issued. Unresolved Tender Bids have not been included in the draft pharmaceutical list (Schedule Two).

Schedule Two: Possible pharmaceuticals for tender for principal supply

Order of pharmaceuticals in this Schedule

Pharmaceuticals have been listed in groups according to the therapeutic group classification system used in the Pharmaceutical Schedule. Below is a list of these groups, and the corresponding page numbers for your ease of reference. Pharmaceuticals with indications that may apply to multiple therapeutic groups will only appear in one group.

Information provided for each pharmaceutical

For each pharmaceutical (as defined by chemical name, form and strength) we have provided the following information:

• the current ex-manufacturer subsidy per unit of measure as at 1 July 2021;
• the number of subsidised or partially subsidised units sold in the community in the year ending 30 June 2021;
• an estimate of the annual community market value at current subsidies (estimated by multiplying the volume of units subsidised in the year ending 30 June 2021 by the relevant listed unit subsidy as at 1 July 2021); and
• comments specifically relating to the Tender Item and/or its current listing on the Pharmaceutical Schedule.

Hauora Arotahi - Māori Health Areas of Focus

The draft 2021/22 Tender includes treatments for mental health, diabetes, heart health (high blood pressure and stroke), respiratory health, and cancer (lung and breast). These are the Māori health areas of focus as voiced by whānau Māori.

Te Pātaka Whaioranga (Pharmac) is continually working to develop and implement advances in these Hauora Arotahi, to best help achieve equitable health outcomes for Māori.

Explanation of terms, symbols and abbreviations

Most terms and abbreviations used are self-explanatory: “tab” means tablet, “cap” means capsule, “liq” means liquid, “inj” means injection, “suppos” means suppository, “grans” mean granules and “OP” means original pack to be dispensed.

The following table explains the symbols used in the draft pharmaceutical list: