Government backs down after patient community complaints reported by Blood Cancer Uncensored and iNews.co.uk but new barrier to life saving treatment has been introduced.

Following reports published here on blood cancer uncensored, and in a press article we helped with on inews.co.uk the government have quietly made plans to drop the requirement for PCR tests to qualify for monoclonal antibodies and antivirals, but not until the 10 February. After this magic cut off date registering a positive lateral flow test (LFT) result online will be enough to qualify for antibody or antiviral treatments. So clearly blood cancer and other immune compromised pateints should make sure they don’t get sick before the 10 February!

The new plans were not formally announced but appear in the latest version of the commissioning policy for community treatment of COVID-19 which was released on Friday 27 Jan. Some CMDUs seem to have implemented this change early, in another example of an unfair post code lottery.

Patients do need to continue to be aware that LFTs can provide false negative results so if you have possible COVID symptoms you must still take a PCR test if your LFT does not detect the virus.

Other problems in the system for getting access to monoclonal antibodies remain, and we can reveal that slipped into the policy there is also a new requirement on the level of symptoms, which is already creating yet another barrier to obtaining rapid access to this life saving treatment.

Online patient forums in the UK continue to be in uproar about the challenges accessing priority PCR kits, getting referred to Covid Medicine Delivery Units (CMDUs), delays in being contacted by the units partly because some apparently do not work seven days a week, and some GP’s and haematologists refusing to refer patients to these units or claiming ignorance of the whole system.

Following a deluge of complaints to various NHS and government bodies about the broken processes, their responses have been unhelpful and they have refused to make any attempt to fix the broken eligibility list of those at highest risk of severe disease due to their immune system.

The highest risk list is a shorter list than the previous CEV list. It is based on published criteria but the computer matching program excluded many who should have been included and included some who should not have been. This list which some parts of the NHS tried to deny even existed is important. The list determined who received priority PCR kits which are required as regular PCR kits are taking much too long to process, dramatically increasing the risk of not being able to get access to antibody treatments in the vital first five days of a COVID19 infection.

The highest risk list also powers an automatic referral system to the CMDUs which is triggered when any patient on the list gets a positive PCR result. Patients not on the list are put at a life threatening disadvantage because they must instead find a GP, hospital doctor or nurse, A and E doctor, or a 111 call handler willing to refer them for this life saving treatment. This process is far from easy at times as blood cancer patients have explained. So this as well as the need for rapid PCR if LFTs are thought to be falsely negative menas the pressure must be kept up on the NHS to fix the list.

Many Helath professionals in the NHS are currently claiming not to know about this system at all, or are making up their own rules about who should be referred. Some patients in Watch and Wait for blood cancer have been told they were not eligible for antibody treatment because they had not yet been treated. This is not the case according to the published criteria which makes it clear that patients with certain types of blood cancer should be treated whatever the stage. Some rarer types of blood cancer such as T lymphoma have, however, been left out of the list despite them causing immune compromise.

Antivirals or monoclonal antibodies are being offered to those lucky enough to get through all the hurdles. Only one monoclonal antibody is currently used in the UK, Sotrovimab. This is known to be active against all variants of COVID-19. Here is a short video clip that explains the fantastic results from its clinical trial:

Patients are also now starting to report that some CMDUs are refusing them treatment because they are not yet sick enough!

A line in the policy which was first slipped into the Christmas Eve update has introduced a new jeopardy and barrier for some patients getting the treatment. This states that in order to qualify for treatment you must be

“Symptomatic with COVID-19 and showing no signs of clinical recovery”

There are two problems with this. Firstly at least one CMDU has used this line as an excuse not to give the treatment too early as there is no way of knowing if your symptoms will improve if you are given the treatment in the first couple of days of a COVID sickness. Delaying treatment in order to see if someone will improve on their own might seem like a good idea, but biologically we know that these treatments are more effective the earlier they are given. So to delay in order to see if someone improves could lead to the treatment not having as much opportunity to work, and in any case deterioration in COVID19 symptoms can happen several days after the five day window.

In fact the symptoms listed in the policy are not all significant or severe, and some of them are very subjective so will depend on the way in which the patient describes how they are feeling.

Our suggestion to patients is that it is important that you tell your doctors ALL your symptoms and also stress your anxiety that you may deteriorate rapidly due to your severe immune compromise. Most blood cancer patients qualify for the label severe immune compromise though of course there is a broad range in how well our immune systems respond to infections. Not all doctors will be aware of how blood cancer affects the immune system.

It may also be worth also knowing your antibody status although that does not determine your eligibility for the treatments. If your system has not produced antibodies in response to a vaccine it is a piece of evidence that supports the idea your immune system is not functioning as it should.

The requirement for having symptoms surely means that if patients under-report their symptoms or say that they are feeling “not too bad” then doctors may decide not to treat on that basis. This could mean that people who are less likely to be open and honest about how they are feeling might not be treated. It could also lead to people not even coming forward for treatment so as not to “be a bother” but then some of those patients might get much more severe disease days later.

It is not medically correct in my view to require significant symptoms early in the COVID19 disease as a requirement for treatment and it is certainly not part of the official clinical trials to wait and see how someone is doing.

Patients who make it through all the hurdles will be given information about several different options for treatment. Choice of which treatment to have is obviously a matter for individual clinical and patient judgement. One strategy which may be worth considering is to take the monoclonal antibodies from the NHS and then also give yourself the chance of getting antivirals at the same time by volunteering for the Panoramic Trial of antivirals.

The Panoramic Trial has broader entry requirements than the current NHS rules for antibodies and antivirals. So if you are turned down for treatment, that is another option you can self refer to. At some point the combination of antibodies and antivirals may be used. Or perhaps we will be given long acting antibodies before we are exposed to COVID19 as they are beginning to do in the USA, and anyone who does get infected despite that would then be eligible for the antivirals.

Learn More

Patient Information on COVID19 Antivirals and Antibodies

Guidance for doctors including a list of CMDU contact information

The Panoramic Trial