Proposal to list and award sole supply to Celecoxib Pfizer

We are seeking feedback on a proposal to:

• list celecoxib 100 mg and 200 mg capsules from 1 June 2017 in Section B and Part II of Section H (Hospital Medicines List) of the Pharmaceutical Schedule with no restrictions.
• award Sole Supply Status and Hospital Supply Status to Pfizer’s brand of celecoxib (Celecoxib Pfizer) from 1 August 2017 until 30 June 2020.
• delist all other oral selective COX-2 inhibitor presentations of the ‘coxib’ class (all strengths of etoricoxib tablets and celecoxib 400 mg tablets) from the Hospital Medicines List from 1 August 2017.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday, 15 November 2016 to:

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

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.

Details of the proposal

New Listing

• From 1 June 2017 Pfizer’s brand of celecoxib 100 mg and 200 mg capsules (Celecoxib Pfizer) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows (ex-manufacturer and excluding GST):

• Celecoxib Pfizer (cap 100 mg and 200 mg) would be awarded Sole Supply Status for oral selective COX-2 inhibitors in the community. This would result in Celecoxib Pfizer being the only funded oral selective COX-2 inhibitor presentation of the ‘coxib’ class in the community from 1 August 2017 until 30 June 2020.
• Celecoxib Pfizer (cap 100 mg and 200 mg) would be awarded Hospital Supply Status for oral selective COX-2 inhibitors in DHB hospitals. This would result in Celecoxib Pfizer being the only available brand of oral selective COX-2 inhibitor presentation of the ‘coxib’ class in DHB hospitals, subject to a 1% DV Limit (i.e. 99% of total volume of celecoxib purchased by DHB hospitals would be required to be Celecoxib Pfizer) from 1 August 2017 until 30 June 2020.

For the avoidance of doubt, the COX-2 inhibitor meloxicam would remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule and the Special Authority criteria and restrictions applying to it would remain unchanged.

Note: Pfizer has had Medsafe approval for celecoxib 100 mg and 200 mg capsules under the brand name Celebrex since 9 September 1999. A Change Medicine Notification (CMN) would be lodged with Medsafe to change the name to Celecoxib Pfizer.

Delisting

• From 1 August 2017 celecoxib cap 100 mg and celecoxib cap 200 mg would be the only listed oral selective COX-2 inhibitor (excluding meloxicam) listed on the Hospital Medicines List and the following oral selective COX-2 inhibitors would be delisted:

Background

Selective cyclooxygenase (COX-2) inhibitors are a type of non-steroidal anti-inflammatory drug (NSAID) that directly targets COX-2, an enzyme responsible for inflammation and pain.

Celecoxib is used for:

• the treatment of symptomatic pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis; and
• the management of acute pain and treatment of primary dysmenorrhoea in adults.

Funding history of selective COX-2 inhibitors

PHARMAC first received a funding application for an oral COX-2 inhibitor in 1999, for meloxicam. This was followed by applications for celecoxib (later in 1999) and rofecoxib (in 2000).

At the time, PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) recommended funding the selective COX-2 inhibitors with a medium priority for patients needing treatment with NSAIDs. From information available at the time, PTAC considered celecoxib appeared to be as effective as other NSAIDs but with a better gastrointestinal safety profile. However, PTAC also considered that the place in therapy and safety profile of celecoxib still needed to be established from post-marketing experience.

In September 2003 the PHARMAC Board made a decision to decline the funding applications for the oral selective COX-2 inhibitors meloxicam (Mobic), celecoxib (Celebrex) and rofecoxib (Vioxx). At the time the Board made its decision, the financial impact associated with funding COX-2 inhibitors was estimated to be substantially higher than would have been possible from within the available pharmaceutical budget. In addition, there was emerging evidence of serious cardiovascular safety concerns for some COX-2 inhibitors^[1].

Two COX-2 inhibitors rofecoxib and valdecoxib were withdrawn from the market by their suppliers, in September 2004 and April 2005, respectively, due to cardiovascular safety concerns.

As with any treatment that is declined for funding, PHARMAC has continued to review the funding of COX-2 inhibitors as new evidence becomes available.

Current Funding

Since September 2010, meloxicam has been funded in the community with Special Authority restrictions as a second line treatment for patients with haemophilic arthropathy. PHARMAC approved the funding on the basis that it was for a very small, well-defined patient group in whom the risk:benefit profile of selective COX-2 inhibitors was considered to be favourable compared with other second-line treatment options. Celecoxib, etoricoxib and meloxicam are also listed on the Hospital Medicines List (HML) for perioperative use for a total of up to 8 days’ use.(external link)

Pharmacology and Therapeutics Advisory Committee Advice

PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) and its Subcommittees have considered COX-2 inhibitors on a number of occasions since the first funding application was received in 1999.

In October 2013, the Rheumatology Subcommittee of PTAC advised that the risks and benefits of COX-2 inhibitors compared with conventional NSAIDs were now much better understood, and recommended that PHARMAC seek updated advice on these agents.

In August 2014, PTAC advised that there may be some benefit of COX-2 inhibitors in patients with low cardiovascular risk who have gastrointestinal side effects from nonselective NSAIDs; patients with high-risk colonic polyps who need to be on NSAIDs; and patients on NSAIDs who have adverse effects from proton pump inhibitors.

PTAC considered that the strength and quality of evidence to support selective COX-2 inhibitors providing similar efficacy to funded NSAIDs is high. PTAC considered that, if funded, the main use of selective COX-2 inhibitors would be for chronic inflammatory pain, acute postoperative pain and acute soft tissue injury.

PTAC considered data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not show that the COX-2 selective agents present a greater risk of serious adverse cardiovascular events than non-selective NSAIDs. However, the Committee considered that all selective COX-2 inhibitors are associated with increased cardiovascular risks.

PTAC recommended that selective COX-2 inhibitors be funded without restrictions only if they were no more expensive than the weighted combined average daily cost of the currently funded NSAIDs, with a low priority.

PTAC considered it may be preferable to limit it to the “coxib” class (i.e. excluding meloxicam), noting that meloxicam is not considered a ‘true’ COX-2 inhibitor as it inhibits COX-1 at a 15 mg dose. PTAC considered that if pricing of the “coxibs” was similar, celecoxib would be the preferred agent as it has the best evidence base for risks and benefits.

Full August 2014 PTAC minutes [download no longer available].

Request for Proposals

Having carefully considered the advice from PTAC and further assessed the competitive landscape, PHARMAC released an RFP for the supply of selective cyclooxygenase-2 (COX-2) inhibitors of the ‘coxib’ class on 1 August 2016.

The provisional agreement with Pfizer which forms the basis of this proposal resulted from that process.

Estimated cost

PHARMAC’s assessment is that, at the prices proposed, the average daily cost of Celecoxib Pfizer would be below the current weighted combined average daily cost of the currently funded NSAIDs (currently approximately $0.20 per day).