Decision to list nintedanib (Ofev) and remove restrictions from tiotropium bromide (Spiriva)

Medicines

Decision

What we’re doing

We’re pleased to announce a decision to list nintedanib (Ofev) and remove the current Special Authority restrictions from tiotropium (Spiriva and Spiriva Respimat) from 1 October 2018, through a provisional agreement with Boehringer Ingelheim NZ Limited.

In summary, this decision will result in the following changes from 1 October 2018:

  • Nintedanib (Ofev) will be listed from 1 October 2018 subject to Special Authority restrictions for idiopathic pulmonary fibrosis. These restrictions are wider than those that currently apply to pirfenidone and will allow earlier access to treatment. 
  • The Special Authority restrictions from tiotropium powder and solution for inhalation (Spiriva and Spiriva Respimat) will be removed from 1 October 2018 accompanied by a net price reduction. This will remove the administrative burden associated with approximately 8500 Special Authority applications per year.
  • There will be minor changes to the Special Authority restrictions that currently apply to pirfenidone (Esbriet, supplied by Roche).
  • This decision will also provide savings that can be used for investment in other medicines.

Any changes to the original proposal?

This decision was subject to a consultation in August 2018. The proposed terms of listing, including commercial terms and Special Authority criteria, were approved as consulted on without any changes except for:

Subsidy by Endorsement

Tiotropium bromide is subsidised only for patients who have been diagnosed as having COPD using spirometry, and the prescription is endorsed accordingly.  Patients who had tiotropium dispensed before 1 October 2018 with a valid Special Authority approval, are deemed to be endorsed. 

  • During the consultation period, we corrected an error in the price and subsidy specified for nintedanib for 150 mg capsules in the consultation document on our website. The corrected details are as below.

Detail about this decision

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.

  • Nintedanib 100 mg and 150 mg capsules (Ofev) will be listed in Section B and Part II of Section H (the Hospitals Medicines List; HML) of the Pharmaceutical Schedule under the subheading Antifibrotics in the Respiratory System and Allergies therapeutic group from 1 October 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Nintedanib

Cap 100 mg

Ofev

60 OP

$2,554.00

Nintedanib

Cap 150 mg

Ofev

60 OP

$3,870.00

Who we think will be most interested

  • Health practitioners and other groups involved in the treatment of respiratory conditions including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All consultation responses received were considered in their entirety in making a decision on the proposed changes.

All responses were supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received and changes we have made after listening to you are outlined below.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50. 

Feedback theme Comment
Nintedanib for idiopathic pulmonary fibrosis
All responses were supportive of the proposal to fund nintedanib for patients with idiopathic pulmonary fibrosis (IPF). It was noted this would be a useful alternative if intolerable side-effects occur with pirfenidone. Noted.

Responders supported the change to a multidisciplinary diagnosis of IPF, although the resource impacts were emphasised, particularly for smaller centers.

A professional body noted its support for this approach and expressed a willingness to help facilitate the discussion of all patients at multidisciplinary meetings so that all centres can access such a meeting regardless of the patient’s location within New Zealand.

This approach has been recommended by our clinical advisory committees and has received widespread support in this consultation given the complexities associated with the diagnosis of IPF.

We recognise this may have an impact on the health sector. We will continue to engage with stakeholders on this and may review our restrictions if we consider that there is the potential for regional inequities in access.

Some respondents queried the use of FVC measures and suggested further widening of access in the following ways:

  1. Removal of the upper limit for FVC. Responders considered that any restrictions based on FVC versus predicted disadvantage those patients with IPF who have coexistent emphysema and those over the age of 80 for whom reliable reference ranges do not exist and extrapolation can result in erroneously high FVC predicated values (and therefore ineligibility).
  2. Removal of the stopping criteria whereby patients must stop treatment if there is a 10% or more decline in predicted FVC within any 12-month period. Although these criteria were used in the clinical trial, responders considered that there is a lack of evidence that previous decline predicts future response. These agents may still be effective in altering the disease trajectory.

We had similar feedback at the time of listing pirfenidone. Based on this feedback we sought additional clinical advice from the Respiratory Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2017 and PTAC in June 2018.

PTAC reviewed the recommendations from the Respiratory Subcommittee (which were supportive of wider access), correspondence from clinicians, information from the supplier, relevant clinical trials and the recommendations and analysis from several overseas jurisdictions, and made the following recommendations:

  • for the Special Authority criteria for pirfenidone to be amended by increasing the upper FVC limit to 90% predicted, and for IPF to be diagnosed by a multi-disciplinary team, with a high priority
  • that the pirfenidone stopping criteria should not be amended at the current time, until robust and higher quality evidence is available.

This proposal for nintedanib is consistent with the recommendations from PTAC, although PHARMAC remains open to considering further widening of access should stronger evidence become available.

New patients are likely to initiate on nintedanib instead of pirfenidone if they qualify for that at the time of diagnosis. Noted. This is consistent with our analysis. 
Support for the wider FVC range of 50% to 90% predicted to apply to pirfenidone also. Noted. This proposal to widen access to nintedanib and not pirfenidone is due to commercial considerations rather than because of clinical differences between the two products. PHARMAC remains open to considering similarly widening access to pirfenidone.
Request for the wastage rule to be applied to nintedanib as it is a high cost medicine and smaller quantities than whole packs may be dispensed on occasion. We have determined that an “original pack” (OP) listing is more appropriate than the wastage rule for this product. The OP rule means pharmacists will be reimbursed for the entire pack regardless of the quantity dispensed.
Tiotropium - removal of the Special Authority restrictions
All responses were supportive of the proposal to remove the Special Authority restrictions from tiotropium to reduce the administrative burden on healthcare professionals. Noted.
There was support an accurate diagnosis of COPD. The respondent considered this should be confirmed by spirometry and noted on the prescription.  We note this schedule rule requirement is present on the other long-acting muscarinic antagonists (glycopyrronium and umeclidinium), although this was not noted in the consultation document.We have now included a similar schedule rule for tiotropium.