Proposal to change access to amino acid infant formula

Medicines Consultation Closed

We are proposing to make changes to the access criteria for funding of amino acid infant formula (AAF) from 1 July 2020.

A decision has been made 

Decision to change funding restrictions for amino acid infant formula – published 21 November 2019

What we’re proposing

We are proposing to make changes to the access criteria for funding of amino acid infant formula (AAF) from 1 July 2020. AAF (brand names Alfamino Junior, Elecare and Neocate) is used as a milk substitute in infants who have an allergy or severe intolerance to cow’s milk and cannot take other funded milk substitutes.

It is currently funded subject to Special Authority restrictions(external link).

In summary these changes would mean:

  • the existing Special Authority would be replaced with a new form that includes two different sets of funding criteria for:
    • infants up to 12 months of age
    • children 12 months of age and over.
  • applications for children 12 months of age and over would need to be made by a paediatrician. This would include paediatric gastroenterologists and paediatric immunologists.
  • applications for infants under 12 months of age would continue to be made by a dietitian, relevant specialist or vocationally registered general practitioner as is currently the case.

The following changes would affect both age groups:

  • access criteria would include patients with ultra-short gut and severe immune deficiency
  • access criteria would require the following information:
    • whether the patient’s cows milk protein allergy/intolerance is IgE mediated or non-IgE mediated;
    • that AAF is required for a nutritional deficiency;
    • that there has been a period of three month since the previous application for AAF; and
    • in cases where extensively hydrolysed formula (eHF) has previously been trialled:
      • there is a valid Special Authority number for eHF; or
      • the trial has occurred in an inpatient setting.

Under PHARMAC’s normal decision-making timeframes, the proposed implementation date of 1 July 2020 would allow at least a nine-month time frame from when we notify of a decision to when the changes would come into effect. This would allow time for clinicians to arrange paediatrician referrals to those patients who need it.

Consultation closes at 5 pm on Tuesday, 13 August 2019 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be as of 1 July 2020?

For infants less than 12 months of age

Most infants under 12 months of age would need to have trialled eHF before they could be started on funded AAF. Current eligible applicants caring for patients under 12 months of age would continue to be able to make applications for funded AAF (refer to the proposed criteria below).

For children 12 months of age or over

Children starting AAF would still need to trial eHF, unless they have severe disease or IgE mediated allergy.

Applications for children 12 months or over would need to be made by a paediatrician. This includes paediatricians, paediatric gastroenterologists, and paediatric immunologists.

These changes are proposed to occur on 1 July 2020 to allow sufficient time for the child to be seen routinely by their prescriber and the next steps in their treatment to be considered, which may involve the scheduling of a paediatric specialist appointment if appropriate.

For general practitioners and dietitians

From 1 July 2020, children prescribed AAF who are 12 months of age or over would need to be seen by a paediatrician, paediatric gastroenterologist or paediatric immunologist. Under PHARMAC’s usual decision-making timeframes, there would be at least nine months from notification of a decision on this proposal to when the changes would take effect. This would allow time for up to two appointments with patients and scheduling of a specialist appointment if required.

For paediatricians

There may be some increased referrals from primary care if this proposal is approved. Clinical advice we have received indicates that the number of patients over the age of 12 months for whom AAF is required would be small and these would be patients with severe gastrointestinal intolerance or allergy who are likely already under the care of a paediatrician. We note that current health pathways recommend that the local DHB paediatric team should be contacted when a patient’s trial of eHF has been unsuccessful; therefore, most of these patients should already be known to the specialist team.

Who we think will be interested

  • Caregivers and whānau of children prescribed treatment for cow’s milk protein allergy (CMPA).
  • Clinicians who manage treatment of CMPA, including general practitioners, dietitians, paediatricians, paediatric gastroenterologists and paediatric immunologists.
  • Community and hospital pharmacies and pharmacists.
  • Suppliers and wholesalers.
  • Ministry of Health.

About CMPA and amino acid infant formula

CMPA is an immunologically mediated adverse reaction to cow’s milk protein, with a prevalence of approximately 2% in infants aged under two years. Allergic reaction to cow’s milk protein can be IgE or non-IgE mediated. The spectrum of reactions ranges from immediate anaphylaxis and food allergy reactions to delayed effects such as atopic eczema.

PHARMAC funds two infant formulae for the management of CMPA: extensively hydrolysed formula (eHF) and amino acid formula (AAF). The difference between the two formulae are the proteins:  eHF is extensively hydrolysed (or broken down) and costs $15.21 per 450 g tin; AAF contains no cow's milk proteins and costs $53.00 per 400 g tin. It is more than three times more expensive to manage infants with AAF than eHF.

eHF should be suitable for most infants who have CMPA and do not have IgE- mediated allergy, those with CMPA IgE-mediated allergy would start AAF as first line. There are some infants with severe forms of non-IgE mediated allergy where a trial of eHF has not been effective. These infants should then be trialled on AAF and forwarded to secondary care for follow up.

Why we’re proposing this

Since 2011 there has been a steady increase in the use, and therefore expenditure, of both eHF and AAF. The majority of this expenditure increase has been on the substantially more expensive AAF, with usage now well above what would be expected based on the prevalence of patients with CPMA who would require AAF.

PHARMAC has sought advice on the best way to manage expenditure on infant formulae while ensuring continued access to AAF for patients who need it.

The Special Foods Subcommittee of PTAC, in July 2015, recommended that all infant formula access should be reviewed individually by a panel of clinicians [PDF, 50 KB]. This recommendation was considered by PHARMAC to be too restrictive and would cause significant administrative burden for clinicians.

The Special Foods Subcommittee was consulted again in December 2017, and recommended that access to AAF be restricted based on the age of the patient, with a requirement that applications for patients 12 months of age and over should be made by a specialist in secondary care [PDF, 564 KB].

The Subcommittee also considered that:

  • many patients are prescribed AAF inappropriately, when eHF would be effective.
  • patients are kept on formula for too long beyond when they should have progressed to solids.
  • there would be a small number of patients on AAF with complicated disease who are 12 months of age and over and all of these patients would be under the care of a paediatric immunologist, paediatric gastroenterologist or general paediatrician.

Details about our proposal

From 1 July 2020, the Special Authority criteria for amino acid formula powder in Section B of the Pharmaceutical Schedule would be replaced as follows (deletion of existing criteria shown in strikethrough and proposed new criteria shown in bold):

Special Authority for Subsidy
Initial application only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Any of the following:

  1. Extensively hydrolysed formula has been reasonably trialled and is inappropriate due to documented severe intolerance or allergy or malabsorption; or
  2. History of anaphylaxis to cows milk protein formula or dairy products; or
  3. Eosinophilic oesophagitis.

Note: A reasonable trial is defined as a 2-4 week trial.
Renewal only from a dietitian, relevant specialist, vocationally registered general practitioner or general practitioner on the recommendation of a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. An assessment as to whether the infant can be transitioned to a cows milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and
  2. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
  3. General Practitioners must include the name of the dietitian, relevant specialist or vocationally registered general practitioner and date contacted.

Proposed new Special Authority for Subsidy as of 1 July 2020 as follows:
Special Authority for Subsidy

Initial application - (Infants under 12 months of age) only from a dietitian, paediatrician, paediatric gastroenterologist, paediatric immunologists or vocationally registered general practitioner.

Approvals valid for 6 months for applications meeting the following criteria:

Both

  1. Patient is under 12 months of age; and
  2. Any of the following:
    1. History of anaphylaxis to cow’s milk protein formula or dairy products; or
    2. Eosinophilic oesophagitis; or
    3. Ultra-short gut; or
    4. Severe Immune deficiency; or
    5. Extensively hydrolysed formula has been trialled in an inpatient setting and is clinically inappropriate; or
    6. Both:
      1. Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; and
      2. Either
        1. The patient has a valid Special Authority approval for extensively hydrolysed formula: approval number; or
        2. Patient has IgE mediated allergy.

Initial application - (Children 12 months of age and over) only from a paediatrician, paediatric gastroenterologist, or paediatric immunologists. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Patient is 12 months of age and over; and
  2. Any of the following:
    1. History of anaphylaxis to cow’s milk protein formula or dairy products; or
    2. Eosinophilic oesophagitis; or
    3. Ultra-short gut; or
    4. Severe Immune deficiency; or
    5. Extensively hydrolysed formula has been trialled in an inpatient setting and is clinically inappropriate; or
    6. Both:
      1. Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; and
      2. Either:
        1. The patient has a valid Special Authority approval for extensively hydrolysed formula: approval number; or
        2. Patient has IgE mediated allergy.

Renewal - (Infants up to 12 months of age) only from a dietitian, paediatrician, paediatric gastroenterologist, paediatric immunologists, vocationally registered general practitioner or general practitioner on the recommendation of a dietitian, paediatrician, paediatric gastroenterologist, paediatric immunologists or vocationally registered general practitioner.

Approvals valid for 6 months for applications meeting the following criteria:

Both

  1. Patient is under 12 months of age; and
  2. Either:
    1. Patient has IgE mediated allergy; and
      1. All of the following:
        1. Patient remains allergic to cow’s milk; and
        2. An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy or extensively hydrolysed infant formula has been undertaken; and
        3. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
        4. Amino acid formula is required for a nutritional deficit; and
        5. General Practitioners must include the name of the dietitian, paediatrician, paediatric gastroenterologist relevant specialist or vocationally registered general practitioner and date contacted; and
        6. It has been more than three months from the previous approval; or
    2. Patient has non IgE mediated severe gastrointestinal intolerance (including eosinophilic oesophagitis, ultra-short gut and severe immune deficiency); and
      1. All of the following:
        1. An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and
        2. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
        3. Amino acid formula is required for a nutritional deficit; and
        4. General Practitioners must include the name of the dietitian, paediatrician, paediatric gastroenterologist or vocationally registered general practitioner and date contacted; and
        5. It has been more than three months from the previous approval.

Renewal - (Children 12 months of age and over) only from a paediatrician, paediatric gastroenterologist, or paediatric immunologists. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Patient is 12 months of age and over; and
  2. Either:
    1. Both:
      1. Patient has IgE mediated allergy; and
      2. All of the following:
        1. Patient remains allergic to cow’s milk; and
        2. An assessment as to whether the infant can be transitioned to a soy or extensively hydrolysed infant formula has been undertaken; and
        3. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
        4. Amino acid formula is required for a nutritional deficit; and
        5. It has been more than three months from the previous approval; or
    2. Both:
      1. Patient has non IgE mediated severe gastrointestinal intolerance; and
      2. All of the following:
        1. An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and
        2. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
        3. Amino acid formula is required for a nutritional deficit; and
        4. It has been more than three months from the previous approval.

Similar changes would also be made to the hospital indication restrictions for amino acid formula in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines list; HML).

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on Tuesday, 13 August 2019.

We are interested in all feedback you may have on this proposal.  In particular, we are interested in feedback on the following points:

  • What this decision would mean for demand on DHB paediatric services?
  • What support would be required for primary care to help implement this change?

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.