Decision to fund aflibercept and rivaroxaban

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Bayer New Zealand Limited for the listing of aflibercept and rivaroxaban in Section B (Community) and in Part II of Section H (Hospital) of the Pharmaceutical Schedule.

What we’re doing

PHARMAC is pleased to announce the approval of an agreement with Bayer New Zealand Limited for the listing of aflibercept and rivaroxaban in Section B (Community) and in Part II of Section H (Hospital) of the Pharmaceutical Schedule.

The above changes were the subject of the consultation letter dated 27 March 2018.

In summary, this decision will:

This decision is likely to benefit approximately 13,000 patients in the first year.

Any changes to the original proposal?

Having considered the consultation feedback, we have amended the aflibercept restrictions so that patients who have previously (prior to June 2018) been treated with ranibizumab and whose disease is currently stable, and patients who are currently being treated with aflibercept with previous documented poor response to bevacizumab, will be able to access funded aflibercept.

No changes have been made to the rivaroxaban proposal following consultation.

Details of this decision

Aflibercept

Aflibercept (Eylea) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2018 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical

Presentation

Brand

Pack size

Price and subsidy

Aflibercept

Inj 40 mg per ml, 0.1 ml vial

Eylea

1

$1,250.00

Aflibercept will have delisting and subsidy protection until 1 June 2020, and a confidential rebate will apply that will reduce the net price of aflibercept to the Funder.

Aflibercept will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

 

Special Authority for Subsidy

Initial application – (wet age related macular degeneration) only from an ophthalmologist.  Approvals valid for 3 months for applications meeting the following criteria: 

Either:

1     All of the following:

1.1 Any of the following:

1.1.1 Wet age-related macular degeneration (wet AMD); or

1.1.2 Polypoidal choroidal vasculopathy; or

1.1.3 Choroidal neovascular membrane from causes other than wet AMD; and

1.2 Either:

1.2.1 The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or

1.2.2 There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and

1.3 There is no structural damage to the central fovea of the treated eye; and

1.4 Patient has not previously been treated with ranibizumab for longer than 3 months; or

2     Any of the following:

2.1   Patient has current approval to use ranibizumab for treatment of wAMD and was found to be intolerant to ranibizumab within 3 months; or

2.2   Patient has previously* (*before June 2018) received treatment with ranibizumab for wAMD and disease was stable while on treatment; or

2.3   Patient has current approval to use ranibizumab for treatment of wAMD; or

2.4   Patient is currently receiving treatment with aflibercept and has documented previous poor response to bevacizumab.

NOTE: Criterion 2.3 and 2.4 will be removed from 1 January 2019.

 

Renewal – (wet age related macular degeneration) only from an ophthalmologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Documented benefit must be demonstrated to continue; and
  2. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
  3. There is no structural damage to the central fovea of the treated eye.

 

Initial application – (diabetic macular oedema) only from an ophthalmologist.  Approvals valid for 4 months for applications meeting the following criteria: 

Either:

1.   All of the following:

1.1   Patient has centre involving diabetic macular oedema (DMO); and

1.2   Patient’s disease is non responsive to 4 doses of intravitreal bevacizumab when administered 4-6 weekly; and
1.3   Patient has reduced visual acuity between 6/9 – 6/36 with functional awareness of reduction in vision; and
1.4   Patient has DMO within central OCT (ocular coherence tomography) subfield >350 micrometers; and
1.5   There is no centre-involving sub-retinal fibrosis or foveal atrophy; or

2.  Patient is currently receiving treatment with aflibercept and has documented previous poor response to bevacizumab.

 

Note: Criterion 2 will be removed from 1 January 2019.

 

Renewal – (diabetic macular oedema) only from an ophthalmologist.  Approvals valid for 12 months for applications meeting the following criteria: 

All of the following:

  1. There is stability or two lines of Snellen visual acuity gain; and
  2. There is structural improvement on OCT scan (with reduction in intra-retinal cysts, central retinal thickness, and sub-retinal fluid); and
  3. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
  4. There is no centre-involving sub-retinal fibrosis or foveal atrophy; and
  5. After each consecutive 12 months treatment with [2nd line anti-VEGF agent], patient has retrialled with at least one injection of bevacizumab and had no response.

 

Aflibercept will be listed in Part II of Section H of the Pharmaceutical Schedule subject to the following Indication Restriction:

 

Restricted

Initiation – Wet Age Related Macular Degeneration

Ophthalmologist

Reassessment required after 3 months

Either:

1     All of the following:

1.1 Any of the following:

1.1.1 Wet age-related macular degeneration (wet AMD); or

1.1.2 Polypoidal choroidal vasculopathy; or

1.1.3 Choroidal neovascular membrane from causes other than wet AMD; and

1.2 Either:

1.2.1 The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or

1.2.2 There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and

1.3 There is no structural damage to the central fovea of the treated eye; and

1.4 Patient has not previously been treated with ranibizumab for longer than 3 months; or

2     Any of the following:

2.1   Patient has current approval to use ranibizumab for treatment of wAMD and was found to be intolerant to ranibizumab within 3 months; or

2.2   Patient has previously* (*before June 2018) received treatment with ranibizumab for wAMD and disease was stable while on treatment; or

2.3   Patient has current approval to use ranibizumab for treatment of wAMD; or

2.4   Patient is currently receiving treatment with aflibercept and has documented previous poor response to bevacizumab.


NOTE
: Criterion 2.3 and 2.4 will be removed from 1 January 2019.

 

Continuation - Wet Age Related Macular Degeneration

Ophthalmologist

Re-assessment required after 12 months

All of the following:

  1. Documented benefit must be demonstrated to continue; and
  2. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
  3. There is no structural damage to the central fovea of the treated eye.

 

Initiation – Diabetic Macular Oedema

Ophthalmologist

Re-assessment required after 4 months

Either:

1.    All of the following:

1.1   Patient has centre involving diabetic macular oedema (DMO); and

1.2   Patient’s disease is non responsive to 4 doses of intravitreal bevacizumab when administered 4-6 weekly; and

1.3   Patient has reduced visual acuity between 6/9 – 6/36 with functional awareness of reduction in vision; and

1.4   Patient has DMO within central OCT (ocular coherence tomography) subfield >350 micrometers; and

1.5   There is no centre-involving sub-retinal fibrosis or foveal atrophy; or

2.  Patient is currently receiving treatment with aflibercept and has documented previous poor response to bevacizumab.

 

Note: Criterion 2 will be removed from 1 January 2019

 

Continuation - Diabetic Macular Oedema

Ophthalmologist

Re-assessment required after 12 months

All of the following:

  1. There is stability or two lines of Snellen visual acuity gain; and
  2. There is structural improvement on OCT scan (with reduction in intra-retinal cysts, central retinal thickness, and sub-retinal fluid); and
  3. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
  4. There is no centre-involving sub-retinal fibrosis or foveal atrophy; and
  5. After each consecutive 12 months treatment with aflibercept, patient has retrialled with at least one injection of bevacizumab and had no response.

Ranibizumab

The restrictions for ranibizumab (Lucentis) vials in Part II of Section H of the Pharmaceutical will be replaced from 1 June 2018 as follows (deletions in strikethrough, additions in bold):

Initiation

Re-assessment required after 3 doses

1      Either:

1.1   Age-related macular degeneration; or

1.2   Chorodial neovascular membrane; and

2     Any of the following:

2.1 The patient has had a severe ophthalmic inflammatory response following bevacizumab; or

2.2 The patient has had a myocardial infarction or stroke within the last three months; or

2.3 The patient has failed to respond to bevacizumab following three intraocular injections; or

2.4 The patient is of child-bearing potential and has not completed a family.

Continuation

Both:

1     Documented benefit after three doses must be demonstrated to continue; and
2     In the case of previous non-response to bevacizumab, a retrial of bevacizumab is required to confirm non-response before continuing with ranibizumab

 

Initiation – Wet Age Related Macular Degeneration

Ophthalmologist

Reassessment required after 3 months

Either:

1     All of the following:

1.1 Any of the following:

1.1.1 Wet age-related macular degeneration (wet AMD); or

1.1.2 Polypoidal choroidal vasculopathy; or

1.1.3 Choroidal neovascular membrane from causes other than wet AMD; and

1.2 Either:

1.2.1 The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or

1.2.2 There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and

1.3 There is no structural damage to the central fovea of the treated eye; and

1.4 Patient has not previously been treated with aflibercept for longer than 3 months; or

2     Patient has current approval to use aflibercept for treatment of wAMD and was found to be intolerant to aflibercept within 3 months.

 

Continuation

Ophthalmologist

Re-assessment required after 12 months

All of the following:

1       Documented benefit must be demonstrated to continue; and

2       Patient’s vision is 6/36 or better on the Snellen visual acuity score; and

3       There is no structural damage to the central fovea of the treated eye.


Rivaroxaban

The following presentations of rivaroxaban (Xarelto) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2018 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical Presentation Brand Pack size Current price and subsidy New price and subsidy
Rivaroxaban Tab 10 mg Xarelto 15 $153.00 $41.55*
Rivaroxaban Tab 10 mg Xarelto 30 - $83.10
Rivaroxaban Tab 15 mg Xarelto 28 - $77.56
Rivaroxaban Tab 20 mg Xarelto 28 - $77.56
* price and subsidy decrease for this pack size from 1 August 2018. 

 

Rivaroxaban will have delisting and subsidy protection until 1 January 2020, and a confidential rebate will apply that will reduce the net price of rivaroxaban to the Funder.

From 1 August 2018, the Special Authority and Indication Restriction requirements for rivaroxaban (Xarelto) 10 mg tablets will be removed. 

Rivaroxaban (Xarelto) 10 mg tablets will have the “not more than 1 tablet per day” restriction applied in Section B (community) of the Pharmaceutical Schedule from 1 August 2018.  This means that if more than 1 tablet per day is dispensed then no subsidy will apply; i.e. this item in its entirely will not be subsidised.  

Who we think will be most interested

  • Patients
  • Clinicians (ophthalmologists, cardiologists, haematologists, surgeons, neurologists, stroke physicians, specialist nurses, general practitioners, and any other relevant healthcare professional)
  • Public ophthalmology departments and private ophthalmology clinics
  • Community and hospital pharmacies and pharmacists
  • Suppliers and wholesalers
  • DHB hospitals
  • Ministry of Health

What will the effect of this decision be?


Aflibercept

From 1 June 2018, eligible patients with a range of ophthalmic conditions, including wet age-related macular degeneration (wAMD) and diabetic macular oedema (DMO), who meet the funding criteria will be eligible to receive funded access to aflibercept – a newer generation anti-VEGF treatment – to preserve and improve vision.

Aflibercept will be listed in both Section B and Part II of Section H of the Pharmaceutical Schedule, so treatment can be accessed in DHB hospitals as well as in the community.

To access community-funded treatment, clinicians will need to apply for a Special Authority (SA) approval in advance of administering treatment to the patient; these can be applied for electronically or manually.

Pharmacies will be able to dispense funded aflibercept on presentation of a prescription with a valid SA approval number. Patients might collect the medicine from the pharmacy and bring it with them to the administration appointment, or the ophthalmology clinic might arrange for the collection of these products on patients’ behalf.

Please note that this medicine must be stored in the fridge between 2º and 8ºC, and must not be frozen. Aflibercept can be stored at or below 25 ºC for up to 24 hours.

 

Rivaroxaban

From 1 August 2018, prescribers will be able to prescribe funded rivaroxaban tablets for any patient where considered clinically appropriate as a Special Authority will no longer apply to rivaroxaban. 

Rivaroxaban is an oral anti-coagulant, generally used for the prevention of stroke and other thromboembolic events in certain patient groups. Rivaroxaban may be particularly useful for those patients who are unable to take, or are intolerant to, the currently funded treatments, warfarin or dabigatran.

Please note that whilst there will be no indication restrictions for rivaroxaban prescribing from 1 August 2018, there will be a one tablet per day limit on rivaroxaban 10 mg tablets. It is intended that this strength will only used for the prevention of VTE. Patients requiring 20 mg rivaroxaban per day can be prescribed the 20 mg strength.

Our response to what you told us

PHARMAC is grateful for the time people took to respond to the consultation. All consultation responses received by 16 April 2018 were considered in their entirety when making a decision.

Responses were generally supportive of this proposal to list aflibercept and rivaroxaban. The table below summarises the main issues raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

Feedback related to aflibercept

Theme

PHARMAC Comment

There is a small number of patients who have previously been trialled on ranibizumab but due to the current criteria wording, have switched back and have been re-stabalised on bevacizumab; responders requested that the restrictions be amended to enable these patients to access funded aflibercept if their disease progresses.

The aflibercept restrictions have been amended to enable these patients to receive funded aflibercept.

There are some patients who have not benefitted from bevacizumab, and are currently either self-funding aflibercept or receiving aflibercept from the supplier on compassionate supply; responders requested that the restrictions be amended to enable these patients to access funded aflibercept.

The aflibercept restrictions have been amended to enable these patients to receive funded aflibercept.

Note that patients who self-fund aflibercept as a first-line treatment, and who have not previously demonstrated poor response to bevacizumab, would not be eligible for funded access to this second-line aflibercept.

Aflibercept is temperature sensitive, and some patients have to travel long distances to reach ophthalmology clinics and may not have the aflibercept stored correctly in transit.

Information should be provided to prescribers and patients to ensure proper storage of this medicine.

We consider it likely that pharmacies and ophthalmology clinics would enter into arrangements to have the aflibercept vials dispensed on a prescription to be delivered to clinics, without the need for patients to pick up this medicine from the pharmacy.

However, in order to support situations where such arrangements are not in place, PHARMAC will work with Bayer to formulate prescriber and patient information sheets, which will include storage instructions.

The need for a Special Authority may mean a second trip to the clinic for patients, which may be a long distance away for some patients.

The Special Authority system can take up to 10 days to process an application.

We understand that faxed Special Authority applications generally take 2-3 days for an approval.

We are also aware that the majority of clinicians use the online Special Authority application system, where approvals are almost instantaneous.

Feedback related to rivaroxaban

Theme

PHARMAC Comment

There were a number of concerns raised around the lack of an available reversal agent, the potential for confusion due to different dosage recommendations between rivaroxaban and dabigatran, potential for clinical errors due to lack of familiarity with rivaroxaban and the need for clinician and patient education about the safe use of rivaroxaban.

While there is not yet a specific reversal agent for rivaroxaban registered or available in New Zealand, our advice from the Haematology Subcommittee of PTAC was that, given the lower renal clearance of rivaroxaban, the likelihood of need for an antidote is likely to be lower than for dabigatran.

We note that dabigatran was listed from July 2011 until September 2016 without an antidote. Measures to control bleeding relied largely on supportive measures outlined in the PHARMAC produced guidelines on the management of bleeding and perioperative management. These guidelines were developed with expert clinical advice from the Haematology Subcommittee of PTAC. We expect these same measures would be taken in the event of rivaroxaban associated bleeding and we will consider whether publication of an update of these guidelines is required prior to listing.

When introducing any new medicine there is potential for patient and/or clinician confusion. PHARMAC will make available information about the safe and appropriate use of rivaroxaban to primary and secondary care health professionals. The Medsafe datasheet for rivaroxaban(or other appropriate information source) should be considered by prescribers prior to prescribing rivaroxaban. (external link)

Community pharmacies would need to understand that there will be different monthly pack sizes available for rivaroxaban 10 mg tablets (30 tablet pack size), and rivaroxaban 15 mg and 20 mg tablets (28 tablet pack size).

PHARMAC will include advice regarding pack sizes in communications to pharmacy.

These pack sizes reflect the currently registered pack sizes in New Zealand. 30 tablet packs for the 15 mg and 20 mg may be available in the future.

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.