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ELIGIBILITY CRITERIA FOR PULMONARY ARTERIAL HYPERTENSION THERAPY (Pharmaceutical Management Agency)

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1
ELIGIBILITY CRITERIA FOR PULMONARY ARTERIAL
HYPERTENSION THERAPY
Contents
Eligibility criteria for Pulmonary Arterial Hypertension therapy........................2 - 6
Initial Application for funding of Pulmonary Arterial Hypertension
treatments.......................................................................................................7 - 13
Renewal Application or request for change of therapy for Pulmonary Arterial
Hypertension treatments.............................................................................. 14 - 18
2
ELIGIBILITY CRITERIA FOR PULMONARY ARTERIAL
HYPERTENSION THERAPY
These guidelines are intended to assist relevant practitioners in gauging which patients are
likely to be approved for pulmonary arterial hypertension (PAH) treatments. Five treatments
are currently funded for PAH. Of these, applications for two – sildenafil and bosentan – are
through standard Special Authorities (SA), while the other three – ambrisentan, iloprost, and
epoprostenol – are through Panel applications.
This document describes the general funded treatment pathway, including treatments both
through regular Special Authorities and Panel applications. For sildenafil and bosentan, no
application to the Panel is necessary. If a patient is seeking a treatment regimen that includes
at least one of sildenafil and bosentan as well as a medicine covered by the Panel, please
make a Panel application as well as completing a regular Special Authority form. Applications
to the Panel may be made by a relevant specialist or a medical practitioner on the
recommendation of a relevant specialist.
Please note that the pharmaceuticals covered by these access criteria have different registered
indications, and that some of the criteria included here are Unapproved Indications. If clinicians
are intending to prescribe any of these pharmaceuticals for an Unapproved Indication, they
should be aware of and comply with their obligations, including those set out in rule 5.5 of the
Pharmaceutical Schedule.
All requested tests should be carried out in line with the relevant professional guidelines.
Patients with pulmonary arterial hypertension who meet the following criteria may be eligible
for initiation of pulmonary arterial hypertension treatment based on current clinical evidence.
3
MONOTHERAPY
A patient’s first treatment must be monotherapy. A patient is expected to start on sildenafil
monotherapy, unless they are:
a) A child with idiopathic PAH or PAH secondary to congenital heart disease, in which
case they may start with bosentan monotherapy.
b) Intolerant of or contraindicated to sildenafil, in which case they may have bosentan
monotherapy, or may apply to the Panel for ambrisentan, iloprost, or epoprostenol
monotherapy. (Epoprostenol monotherapy may only be applied for in patients meeting
the criteria described further below.)
A patient will need to complete three months of a monotherapy treatment before combination
treatments will be considered.
DUAL THERAPY
To be eligible for dual therapy, a patient must either have:
• Tried a monotherapy for three months with no response, or
• Have deteriorated while on a monotherapy, as determined by:
o Clear evidence of deterioration in right heart cardiac catheterisation measures;
or
o 15% deterioration in two 6 minute walk tests (6MWTs) done at least two weeks
apart; or
o NYHA/WHO functional class IV (the NYHA/WHO functional classification for
PAH replicated on page 4).
For patients who are tolerant of sildenafil, one of the two agents must be sildenafil. Use of
epoprostenol is restricted as described further below. Beyond that, clinicians may apply for any
dual combination.
If a patient does not respond to a particular dual combination or deteriorates as described
above, the clinician may apply for another dual therapy, noting the above restrictions still apply.
TRIPLE THERAPY
Triple therapy for patients on the lung transplant list
A patient on the lung transplant waiting list may apply for triple therapy. Any combination may
be applied for, as long as sildenafil-tolerant patients include sildenafil as one of the three
agents.
Triple therapy for patients for not on lung transplant list
A patient not on the lung transplant list may apply for triple therapy if:
a) The triple therapy would consist of sildenafil, bosentan, and any one other agent, and;
b) The patient meets any one of the following three criteria:
1. Patient presents acutely with idiopathic pulmonary arterial hypertension (IPAH) in New
York Heart Association/World Health Organization (NYHA/WHO) Functional Class IV; or
2. Patient is deteriorating rapidly to NYHA/WHO Functional Class IV and may be a lung
transplant recipient in the future, if their disease is stabilised; or
3. Patient has PAH associated with the scleroderma spectrum of diseases (APAHSSD)
who have no major morbidities and are deteriorating despite combination therapy.
QUARDUPLE AND QUINTUPLE THERAPY
Treatments with four or more PAH agents are not funded.
4
USING EPOPROSTENOL WITHIN ONE OF THE ABOVE THERAPIES
Epoprostenol may only be applied for when patients meet one of the following criteria:
1. Patients presenting acutely with idiopathic pulmonary arterial hypertension (IPAH)
in New York Heart Association/World Health Organization (NYHA/WHO) Functional
Class IV; or
2. Patients deteriorating rapidly to NYHA/WHO Functional Class IV who may be lung
transplant recipients in the future, if their disease is stabilised; or
3. Patients with PAH associated with the scleroderma spectrum of diseases
(APAHSSD) who have no major morbidities and are deteriorating despite
combination therapy, or
4. For use as a bridge to transplant for patients with pulmonary arterial hypertension
who are on the active waiting list for lung transplantation.
Epoprostenol may be applied for as monotherapy or as part of a dual or triple therapy, provided
all other conditions are met.
Patients eligible for approval of treatment by the PAH Panel
Where an application is put to the Panel for consideration (instead of through the standard
Special Authorities), the following conditions must be met:
1. The patient must have a diagnosis of pulmonary arterial hypertension with the following
WHO (Venice) clinical classifications:
• Group 1
▪ Idiopathic;
▪ Familial;
▪ Associated with:
Connective tissue disease;
Congenital systemic pulmonary shunts;
Portal hypertension;
HIV infection;
Drugs and toxins;
Other;
▪ Associated with significant venous or capillary involvement:
Pulmonary veno-occlusive disease (PVOD);
Pulmonary capillary haemangiomatosis (PCH);
▪ Persistent pulmonary hypertension of the newborn (PPHN) including:
1. persistent pulmonary hypertension associated with
premature/neonatal severe chronic lung disease or congenital
diaphragmatic hernia
2. infantile severe chronic lung disease where there is supportive
evidence that the pulmonary vascular resistance had never
normalised
• Group 4
▪ Pulmonary arterial hypertension due to thrombotic and/or embolic disease
only
• Group 5
▪ Miscellaneous group
e.g. sarcoidosis, histiocytosis X and lymphangiomatosis
5
Patients with PAH classified as group 2 or 3 are not eligible for subsidised treatment.
• Group 2 – pulmonary hypertension associated with left heart disease
• Group 3 – pulmonary hypertension associated with respiratory diseases and / or
hypoxaemia.
Lung function tests and cardiac function tests must be supplied with the first Panel
application.
2. The patient must be in NYHA/WHO functional class II, III, or IV. Patients who are
functional class I are not eligible for subsidised treatment.
New York Heart Association / World Health Organization Functional Classification of
Pulmonary Hypertension
Class I:
Patients with pulmonary hypertension but without resulting limitation of physical
activity. Ordinary physical activity does not cause undue dyspnoea or fatigue, chest
pain, or near syncope.
Class II:
Patients with pulmonary hypertension resulting in slight limitation of physical activity.
They are comfortable at rest. Ordinary physical activity does not cause undue
dyspnoea or fatigue, chest pain, or near syncope.
Class III:
Patients with pulmonary hypertension resulting in pronounced limitation of physical
activity. They are comfortable at rest. Less than ordinary activity causes undue
dyspnoea or fatigue, chest pain, or near syncope.
Class IV:
Patients with pulmonary hypertension with inability to carry out any physical activity
without symptoms. These patients have manifest signs of right heart failure.
Dyspnoea and/or fatigue may even be present at rest. Discomfort is increased by
any physical activity.
3. Right cardiac catheterisation data
1
must be supplied with the application. If cardiac
catheterisation is contraindicated, a letter of explanation is required. Unequivocal,
significant evidence of raised pulmonary arterial pressure, in the absence of significant left
heart disease, must be demonstrated.
• The patient must have a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
(patients with a PCWP between 15 mmHg and 18 mmHg may be considered at
the Panel’s discretion).
• The patient must have a mean pulmonary artery pressure (PAPm) > 25 mmHg
unless the patient is peri Fontan repair (see below).
• The patient must have a pulmonary vascular resistance (PVR) of:
▪ > 3 Wood Units; or
▪ > 240 International Units (dyn s cm
-5
)
• An assessment of vasoreactivity has been carried out using iloprost, adenosine
or nitric oxide. Where this assessment has not been carried out, applicants must
1
Grossman, W (Ed). Cardiac Catheterization and Angiography, 3rd ed, Lea & Febiger, Philadelphia
1986
6
provide reasons for this. (Vasoreactivity studies are not mandatory in patients with
severe PAH (functional class IV or right atrial pressure > 12 mmHg or Cardiac
Index < 2 L/min/m
2
) or PAH associated with connective tissue disease.)
• Where the patient has been shown to be vasoreactive (defined as a fall in mean
PAP of greater than or equal to 10mmHg to less than 40mmHg with either an
increase or no change in cardiac index), evidence of an adequate therapeutic trial
of calcium channel blockers for three to six months must have been undertaken,
followed by re-catheterisation demonstrating evidence of haemodynamic
progression. (Due to the negative inotropic effects of CCBs, a trial of CCBs is not
required in patients with severe disease as defined above.)
• For children peri Fontan repair, haemodynamic data is required and formal
cardiac catheterisation should be considered at a clinically appropriate stage of
the patient’s management. Due to the presence of a non-pulsatile circuit a mean
pulmonary artery pressure (PAPm) < 25mmHg would be acceptable.
4. Persistent pulmonary hypertension of the newborn associated with severe chronic lung
disease (CLD) or congenital diaphragmatic hernia (CDH).
• The application must include an inpatient management summary, admission
history, echocardiogram, and short and long term management plan (including
weaning plan).
• Cardiac catheter should be considered for patients with CDH or CLD at a clinically
appropriate stage of the patient’s management where treatment is required for 12
months or more.
7
First Panel Application for Funding of Pulmonary Arterial
Hypertension Treatments
• Use this form if this is the first time an application has been submitted to the PAH Panel
for funding for this patient.
• Please complete as much of the form as possible, noting that not all questions will be
relevant for children under 10 years old.
Please send applications to:
Applications must be complete and
accompanied by supporting data as required.
Have you attached:
Cardiac catheterisation reports
Lung function tests
Echocardiography report
Vasoreactivity data
CCB trial results
Email:
Post:
Fax:
Phone:
Patient Details – patient sticker is acceptable
Last name:
First name/s:
NHI number:
Gender:
Male
Female
Other
Date of birth
Address:
Phone:
Home:
Work:
Mobile:
Email:
Physician Details
Full name:
NZMC number:
Title
Department or Practice address:
Phone:
Mobile:
Fax:
Email:
Signature of applying
physician:
8
Requested regimen
Monotherapy
Dual therapy
Triple therapy
Treatment(s) requested for Panel consideration
Ambrisentan
Iloprost
Epoprostenol
Other PAH treatments that would be used with the above
Sildenafil
Bosentan
Prior treatments
This would be the patient’s first treatment for PAH
The patient has previously trialled:
Current or treatments tried
Dose and duration
Response of the patient
Please discuss the rationale for the proposed treatment regimen:
(if more space is required, please attach a separate document)
9
If sildenafil is not part of the proposed regimen, please explain why:
Basis of request for PAH treatments
Diagnosis
Tick
Patient has been diagnosed as having pulmonary arterial hypertension
NYHA/WHO functional class
2
3
4
WHO (Venice) clinical classification
Group One – Pulmonary arterial hypertension
Idiopathic PAH
Familial PAH
Associated with other diseases:
Connective tissue disease
Congenital systemic pulmonary shunts
Portal hypertension
HIV infection
Drugs/toxins
Other (specify):
Associated with significant venous or capillary involvement
Pulmonary veno-occlusive disease
Pulmonary capillary haemangiomatosis
Persistent pulmonary hypertension of the newborn
Group Four – Pulmonary hypertension due to chronic thrombotic and/or embolic disease only
Group Five – Other pulmonary hypertension (specify):
10
Test results
Height (cm):
Weight (kg):
BMI (kg/m
2
):
Blood pressure
Lung function – Please report as actual values and percent predicted, and attach report
Date of test:
Actual
Percent predicted
FEV
1
FVC
FEV
1
/FVC (%)
DLCO
DLCO/VA
TLC
Six minute walk test:
Date of test:
Distance walked (m):
SpO2:
Baseline:
Nadir:
Heart Rate:
Baseline:
Maximum:
Borg Index:
Pre:
Post:
Brain natriuretic peptide
(BNP):
BNP
Reference
Range:
Information on patients under 10 years old
Gestation at birth:
Birth weight
(centile)
Current oxygen
use:
Saturations
On room air
On oxygen at Litres/min:
Results of overnight oximetry:
11
Chest X-ray findings:
Actual
Percent predicted
FEV
1
FVC
Right Heart Cardiac Catheter (please attach reports)
Date of test:
Testing centre:
Pre vasoreactivity
testing
Post vasoreactivity
testing
Pulmonary capillary wedge
pressure:
(Threshold ≤15 mmHg, or ≤18
mmHg at the Panel’s discretion)
Pulmonary
artery
pressures:
Mean:
Systolic:
Diastolic:
Mean right atrial pressure:
Pulmonary
vascular
resistance:
Wood units
(Threshold > 3)
International
units
(Threshold
>240)
Cardiac output:
Cardiac index:
Vasoreactivity
Has the patient been assessed for vasoreactivity using iloprost,
adenosine or nitric oxide? If no, please provide reasons:
Yes
No
12
Cardiac catheterisation contraindicated:
Discussion:
Calcium channel blocker (CCB) history
• If the patient has idiopathic PAH, is vasoreactive, and has had a trial of CCBs for at least three
months (preferably six), please attach re-catheterisation data demonstrating disease progression
despite CCB treatment.
• If necessary, please provide discussion of CCB treatment:
Echocardiography (please attach full report)
Date of test:
Echo RVP
Echo RAP
Medical History
Transplant status:
Not suitable for referral/turned down
Not yet referred
Inactive waiting list
Active waiting list
Smoking status:
Smoker
Smoker and offered smoking cessation counselling and treatment
Ex-smoker — please state length of time:
Non-smoker
13
Current and relevant medications (including CCBs):
Comorbidities:
Would you like to make any other comments in support of this application?
14
Renewal Application or Request for Change of Therapy for
Pulmonary Arterial Hypertension Treatments
• Use this form if this patient has previously been approved by the PAH Panel for funding.
• Please note that the criteria for funding of sildenafil and bosentan changed on 1 February
2018. An application to the PAH Panel is no longer necessary for those medications.
Applications to the Panel are still required for all other PAH medications.
Please send applications to:
Applications must be complete and
accompanied by supporting data as required.
Have you attached:
Cardiac catheterisation reports
Lung function tests
Echocardiography report
Vasoreactivity data
CCB trial results
Email:
Post:
Fax:
Phone:
Patient Details – patient sticker is acceptable
Last name:
First name/s:
NHI number:
Gender:
Male
Female
Other
Date of birth:
Address:
Phone:
Home:
Work:
Mobile:
Email:
Physician Details
Full name:
NZMC number:
Title
Department or Practice
address:
Phone:
Mobile:
Fax:
Email:
Signature of applying
physician:
Date:
15
Current treatments:
Dose:
Sildenafil
Bosentan
Ambrisentan
Iloprost
Epoprostenol
Change or continuation
This is a request to continue a previously approved therapy:
This is a request to change to a difference therapy, as below:
Requested regimen
Monotherapy
Dual therapy
Triple therapy
Treatment(s) requested for Panel consideration
Ambrisentan
Iloprost
Epoprostenol
Other PAH treatments that would be used with the above
Sildenafil
Bosentan
16
If applying for a change of therapy or combination therapy, please indicate reasons for change:
Intolerance of current treatment (please provide details below)
Lack of response to current treatment (please provide details below)
Disease progression following previous disease stability (please provide details below)
Please discuss the rationale for requesting a change in treatment:
(if more space is required, please attach a separate document)
17
Status Update
NYHA/WHO functional class
2
3
4
Test results
Height (cm):
Weight (kg):
BMI (kg/m
2
):
Blood pressure
Six minute walk test (x2 if annual renewal ie measured every six months):
Distance walked (m):
SpO2:
Baseline:
Nadir:
Heart Rate:
Baseline:
Maximum:
Borg Index:
Pre:
Post:
Brain natriuretic peptide if available – please
provide reference data:
Right heart cardiac catheter (please attach report)
All patients: Repeat cardiac catheter reports must be provided one year after the start of
treatment.
▪ Stable patients: cardiac catheter reports are required at 2 to 4 year intervals
depending upon patient progress.
▪ Unstable patients: Where escalation of treatment is requested, a repeat right heart
cardiac catheter is mandatory.
Testing centre:
PulmonaryFapillaryZedge
pressure:
(Threshold ≤15 mmHg, or ≤18 mmHg
at the Panel’s discretion)
Pulmonary
artery
pressures:
Mean:
Systolic:
Diastolic:
Mean right atrial pressure:
Pulmonary
vascular
resistance:
Wood units
(Threshold > 3)
International
units
(Threshold
>240)
Cardiac output:
Cardiac index
18
Cardiac catheter contraindicated:
Discussion:
Echocardiography (please attach full report)
Date of test:
Echo RVP
Echo RAP
Current symptoms / general well-being over previous 6 or 12 months (as applicable)
(if more space is required, please attach a separate document)
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