On 26 August 2022, the High Court in Pretoria handed down judgement in an application concerning a three-year old boy, Zachary De Wet, suffering from a rare genetic condition called Mucopolysaccharidosis Type II (“MPS II”) - also known as Hunters Syndrome.

Background

During August HJW ATTORNEYS successfully assisted Rare Diseases South Africa ("RDSA") in bringing an application to the High Court of Pretoria on an urgent basis on behalf of Zachary de Wet, a three-year old child who was diagnosed with a rare genetic condition called Hunter’s Syndrome MPS II. Whilst there is no cure for Hunter’s Syndrome, evidence exists that a certain drug called Elaprase can slow and even halt the progression of this horrific and deadly degenerative disease. It is the only registered treatment that exists for Hunters Syndrome. Unfortunately Zachary’s medical aid, Medihelp, had rejected payment of this treatment which is totally unaffordable to an individual with costs of close to R200 000/month.

When Zach’s family approached us, through Rare Diseases SA, we jumped at the chance to get involved and very quickly instituted urgent proceedings to try to get his treatment paid for as his doctors had advised that every day that he went without treatment would render him more and more debilitated.

The Basis for Medihelp’s Decline

Medihelp’s argument and motivation for declining treatment was based on the following reasons:

1.    that Zachary’s condition, MPS II, is not a registered Prescribed Minimum Benefit (“PMB”);

2.    that even if MPS II were a PMB condition, that the requisite treatment is not available in the state for this indication and thus it is not a PMB entitlement;

3.   that Zachary’s benefit plan – MediVital Elect, did not cover chronic medications that do not qualify as a PMB level of care, and further

4. that Zachary’s benefit plan – MediVital Elect, does not cover treatment with biological/biosimilar medicines, which ERT treatments are.

What Is A PMB Condition?

Only once court proceedings were instituted did Medihelp concede that MPS II was indeed a PMB Condition. A PMB Condition is a specific condition set out in the Medical Schemes Act which requires all medical aids to pay for certain health services, related to that condition, regardless of the benefit option they have selected. In terms of the MSA, all medical schemes are required to cover the costs related to the diagnosis, treatment and care of:

·       any emergency medical condition;

·       a limited set of 271 medical conditions (defined in the Diagnosis Treatment Pairs); and

·       26 chronic conditions (defined in the Chronic Disease List).

One of the underlying purposes of the PMB provisions in the Act and the regulations is to ease the demand upon public resources, which provide hospital and medical services at little or no cost, while at the same time ensuring that members of the medical scheme suffering from PMB conditions are able to obtain treatment at a satisfactory level – namely a “PMB Level of Care”.

What is  a PMB Level of Care?

It was at this point that our argument, (and Medihelp’s) became tricky…. This is because not ALL treatments for PMB conditions are required to be funded by a medical aid, but rather only the specific treatments generally specified for them. The regulations to the MSA state that where medical care for a PMB Condition is prescribed in “general terms”, as it is for MPSII, where it is stated that the Prescribed Level of Care is “Medical Management”, that the treatment to be covered must be the same as the treatment which is the “prevailing predominant public hospital practice” for that PMB Condition. Unfortunately, as Zachary’s disease is so rare, it was difficult to establish what the actual “prevailing practice” was as, whilst some patient’s with MPSII are treated in State hospitals,  no formal, written protocols exist to determine what treatment the MUST have. As a result of this, Medihelp argued that the prevailing practice for MPSII was palliative care only and that Elaprase didn’t fall into this category.

With the help of Rare Diseases SA, we were however able to establish that Enzyme Replacement Therapies (of which Elaprase is one) are indeed provided in certain centres of excellence where rare diseases are treated throughout South Africa, including at the Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) and Red Cross Children’s Hospital in Cape Town.

The Judgment

Our application was heard by Honourable Justice Millar J at the High Court  of Pretoria on the 23 August 2022, whereafter he handed down judgement on 26 August 2022.

As we were able to  establish in our argument that Elaprase is in fact available and used in both the public and private healthcare services for the treatment of MPS II – the Honourable Justice Millar J stated that “it seems to me to be self-evident that if ‘prevalence’ or ‘predominance’ are to be the criteria upon which the use of Elaprase is to be measured then it must be so measured within the context of the very low patient numbers”.

Accordingly, Millar J found in our favour and ultimately handed down the following order:

• the condition that Zachary has been diagnosed with, MPS II, is declared a PMB level of care under the category 901K as listed in Annexure A of the Regulations of the Medical Schemes Act, 131 of 1998;

• pending the resolution of part B (a formal complaint to the Council for Medical Schemes) Medihelp are ordered to authorise the treatment and care costs of all medical interventions required by Zachary, which treatment includes inter alia, Elaprase, a registered ERT, within 30 days of the order; and

Justice Millar also ordered Medihelp to pay all the costs of the application.

The Way Forward

It must be noted that for procedural reasons, this application was brought on a part A and part B basis - Part A: requesting Medihelp to fund the treatment of Elaprase, pending the resolution of Part B and Part B: stating that we would await final adjudication by the Council for Medical Schemes as to whether or not this medication is required to be paid for. The CMS is the Body which usually hears and adjudicates complaints of this nature but approaching the CMS first was not an option for Zach, as the processes under the MSA, which include two possible appeal options are time consuming and protracted and did not cater for the urgent relief that Zach required.

In the interim and pending the outcome of the CMS process, which has begun, Zachary is currently receiving the treatment he needs which will allow him to live a longer and healthier life.

We are optimistic that the CMS will rule in Zachary’s favour and that Zach can then continue to receive this life-sustaining treatment for the rest of what we hope will be a very long life for him!

Written by Megan Harrington-Johnson and Alexi Jean Rosenzweig

This article is provided for informational purposes only and should not be substituted for legal advice on any specific matter. Any opinions expressed herein are subject to the law as at the time of writing and will change in accordance with any change in the law. We recommend that you contact HJW Attorneys at info@hjw.co.za directly for advice applicable to your specific matter.